United States Region 10 Alaska
Environmental Protection 1200 Sixth Avenue Idaho Agency Seattle WA 98101 Oregon Washington

August 2007 

## Framework for Selecting and Using Tribal Fish and Shellfish Consumption Rates for Risk-Based Decision Making at CERCLA and RCRA Cleanup Sites in Puget Sound and the Strait of Georgia



## Working Document

To Be Applied in Consultation with Tribal Governments on a Site-specific Basis

Revision 00



### Office of Environmental Cleanup

Office of Air, Waste and Toxics
Office of Environmental Assessmentii This Framework is not intended to replace government-to-government consultation on specific sites. EPA’s release of the Fr amework does not imply concurrence by the Tribes. Nothing in this Framework will lim it, modify, or change Tribal treaty rights.iii This page intentionally left blank.iv Table of Contents Page

Executive Summary 1

I. Introduction 3

II. Application of the Framework 4

III. Key Considerations 6

IV. Steps for Selecting the Tribal Fish and Shellfish Consumption Rate 13

V. Selection of Species for Collectio n of Chemical Contaminant Data and Derivation of Exposure Point Concentr ations when Data for Multiple Species within a Species Group are Available 19

VI. Uncertainties 22

VII. Risk Communication and Risk Ma nagement Issues 27

XIII. Five-Year Review Considerations 28

IX. References 30

Flow Sheet [Note: The Flow Sheet is include d as a separate file in electronic copies of the Framework.] Step 1: Select Basis for Tribal Fish and Shellfish Consumption Rate Step 2: Select Fish and Shellfish Co nsumption Rate and Consideration of
Site- related Contaminants

Appendices
A: Development of the Framework for Selecting and Us ing Tribal Fish and Shellfish Consumption Rates for Risk-B ased Decision Making at CERCLA and RCRA Cleanup Sites in Puget So und and the Strait of Georgia

B: Fish and Shellfish Mixtures from Tribal-Specific Consumptio n Studies

C: Background Information on the Ca lculation of Fish and Shellfish Consumption Rates.

D: Section IV Applied to a Simple Hypothetical Sitev This page intentionally left blank.1 

### Executive Summary

This document presents a conceptual Framew ork for selecting and using Tribal fish and shellfish consumption rates for purposes of estim ating site-related risks at U.S. Environmental Protection Agency (EPA) hazardous waste clean up sites in Puget Sound and the portion of the Strait of Georgia that is within the United States. It is specifica lly intended for use at sites that are addressed through the Resource Conserva tion and Recovery Act (RCRA) and the Comprehensive Environmental Response, Comp ensation, and Liability Act (CERCLA, also known as Superfund.) EPA will consult with Tribes on site-specific exposure assumptions and cleanup decisions at each Superfund and RCRA site within a Tribal fishing area or on Tribal
land. The Framework’s function is to assi st EPA Region 10 staff in managing RCRA and CERCLA cleanups in consideration of information that reflects Tribal exposures and concerns.

The Framework is not intended to repl ace government-to-government consultation on specific sites. EPA’s release of the Framework does not imply concurrence by the Tribes. Nothing in this Framework will limit, m odify, or change Tribal treaty rights.

One of the numerous pieces of informati on needed to estimate potential human health
risks due to chemical contamina tion at cleanup sites is exposure to site-related contamination via consumption of fish and shellfish. Consumpti on of locally harvested fish and shellfish by American Indians is likely to be higher than it is for the gene ral U.S. population. Consumption rates may be drawn from various sources. In this document, highest preference is given to consumption rates derived from well-designed consumption surveys of Puget Sound Tribes, and lowest preference to default values from nationwide food intake studies. Local consumption rate data (95th percentile, uncooke d weight, harvested from Puget Sound) were derived from fish and shellfish consumption studies for the Suquami sh Tribe and the Tulalip Tribes. Consumption rates derived from the Suquamish Tribe data are mo st applicable to cleanup sites with extensive intertidal habitat capable of sustained shellfish harvest. Consumption ra tes derived by EPA from the Tulalip Tribes data are more applicable where such habitat is not extensive. In addition, where a Tribal-specific survey exists and where a cleanup site is within that Tribe's exclusive usual and accustomed harvesting areas, the fish consumption exposure scenarios should include the consumption rate based on that Tribe's survey data.

Site-specific and Tribal-specific factor s should be considered when applying the Framework. If justifiable, specific chemicals may be excluded from the estimates of site-related risks. For example, chemicals may be excluded if they do not accumulate in a particular type of locally harvested fish and shellfis h, or if the chemicals are unrelate d to the site. Modification of exposure assumptions may be appropriate for exposure durat ion and consumer body weight, depending upon availability of data for the pote ntially exposed Tribal population. In this Framework, it is assumed that Tribal members s ubstitute different types of fish and shellfish when those that would preferentially be harvested are unavailable.2 Uncertainties are inherent in all risk assessments, including those performed using this
Framework. A number of those uncertainties ar e summarized in the Fram ework. Site-specific
risk characterizations should in clude a description of uncertaintie s and their potential effects on
estimated risks.3 I. Introduction

Potential human health risks 1 due to chemical contamination are among the many factors that affect EPA Region 10’s cleanup decisions at RCRA and CERCLA sites in Puget Sound and the portion of the Strait of Georgia that is wi thin the United States. Many CERCLA and RCRA cleanup sites located in EPA Region 10 have co ntaminated sediments or surface water, or include upland soil and groundwater that may release hazardous substances or hazardous
constituents to sediment and surface water. Contaminants in sediments and surface water may
then contaminate fish and shellfis h. One of the inputs needed to calculate human health risks is exposure to contaminants via consumption of fish and shellfish. On the basis of data from the few fish and shellfish consumption surveys by or of American Indian Tribes within Region 10, Tribal consumption rates at cleanup sites with in reservation lands or Tribal usual and accustomed harvesting areas 2 (U&A) are likely to be higher th an for the general U.S. population. The National Congress of American Indians (200 4) published a resolution calling for EPA to “use fish and shellfish consump tion rates appropriate to Tribal consumers when it makes cleanup
decisions.” Modifications to stan dard risk assessment assumptions thus may be warranted. This document presents a conceptual Framework for se lecting Puget Sound and th e Strait of Georgia Tribal fish and shellfish consumption rates.

Risk assessment is the process used by EP A to estimate the degree of risk posed by exposure to site-related chemical contaminants. It is also used to develop preliminary cleanup goals. Risk management is a subsequent agency process that deals with decisions regarding how
much of the contaminant should be removed from the environment, based on considerations of background concentrations, site-specific contri butions, human health and ecological impacts, cost-effectiveness of remedial options, and state, Tribal and community i nput. By Federal law, Superfund and RCRA risk assessments and selection of remedies must be protective of human
health and the environment.

The Framework provides a recommended appr oach for selecting fish and shellfish consumption rates where Tribal consumption of fish and shellfish from Puget Sound and the Strait of Georgia is evaluated in EPA’s risk assessment process for RCRA and CERCLA sites. The approach reflects existing EPA guidance a nd policies regarding th e exposures due to
releases from contaminated sites. This Framewor k is designed to provid e a consistent approach to developing fish and shellfish consumption ra tes and to assist decision makers with risk management decisions. The process used to develop this Framework is summarized in Appendix A.

1 The term “risk” in this Framework pr imarily is used to generically describe both excess cancer risks and noncancer hazards. Where quantitatively addressed, cancer ri sks and noncancer hazards are distinguished.

2 Usual and accustomed harvesting areas is a term described by the Northwest Indian Fisheries Commission, at http://www.nwifc.wa.gov /shellfish/faq.asp.4 II. Application of the Framework

This Framework is intended to be applicab le at EPA cleanup sites within Puget Sound and the Strait of Georgia. It does not attempt to include risk s from all fish and shellfish consumed by Tribal members, but only that porti on potentially affected by contaminants released at a cleanup site.

The fish and shellfish consumption data us ed in this Framework are derived from two Tribes in Puget Sound: the Suquamish Tribe (S uquamish Tribe, 2000) and the Tulalip Tribes (Toy et al ., 1996). The studies were designed to include all Tribal members, not only “subsistence” consumers of fish and shellfish. Definitions of “subsistence” vary, but include “fishers who rely on noncommercially caught fish and shellfish as a major source of protein in their diets” (EPA, 2000c).

Fish and shellfish consumption rates develope d for risk assessments for the general U.S. population may not be adequately protective for other populations in Puge t Sound and the Strait of Georgia. For example, rates of fish and shellfish consumption by Seattle-area Asians and Pacific Islanders in one study were higher than those of the general U. S. population (Sechena et al ., 1999). However, this Framework does not addr ess exposure assumptions for groups other
than American Indians. It does not address ecological risks, which are typically evaluated separately when conducting a baselin e risk assessment or establishi ng risk-based cleanup levels. As the Framework addresses only fish and shellfish consumption, other site-specific exposures to Tribal members, such as direct contact with contaminated sediment and surface water, also
should be considered and evaluated.

The Framework is a working document, to be modified as new information is acquired on Tribal consumption patterns, contaminant accumu lation in fish tissues, and other scientific advances, or as agency policies change. The Fr amework’s function is to assist EPA Region 10 staff in managing RCRA and CERCLA cleanups in consideration of inform ation that reflects Tribal exposures and concerns. The Framework does not substitute for statutes EPA administers or their implementing regulations, nor does it hold the status of a regul ation. Thus, it does not impose legally binding requirements on EPA, Tribes , states, or the regulated community. EPA Region 10 staff retains the discretion to use other scientifically defensible methods to select exposure assumptions on a case-by-case basis.

Although CERCLA and RCRA share a common goal

− to protect human health and the environment by cleaning up contaminated sites

− they were mandated separately by Congress and follow different administrative procedures. Th is Framework is intend ed to be applied to future decisions in the RCRA and CERCLA programs.

For baseline risk assessments, the Fram ework may be appropriate to use when contaminated soils, groundwater, surface water, or sediments may affect fish and shellfish harvested and consumed by Tribal members. At CERCLA sites where a remedy is required, the Framework may be used to evalua te various remedial alternatives . At RCRA sites where interim5 or final corrective measures are necessary, the Framework may be used in the development of risk-based cleanup levels.

In keeping with EPA Region 10's Tribal Consultation Framework (EPA, 2001), EPA will
continue to consult with Trib es on site-specific exposure assu mptions and cleanup decisions at each Superfund and RCRA site within a Tribal fish ing area or on Tribal land. If only one Tribal fish consumption exposure scenario is analyzed, this Framework encourages development of that scenario using the exposure assumptions estab lished herein. Additional exposure assumptions should be considered, if the Trib e believes they would better represent exposure of Tribal members. In addition, where a Tr ibal-specific survey exists and where a cleanup site is within that Tribe's exclusive U&A, the fish consum ption exposure scenarios should include the consumption rate based on that Tribe's survey da ta. EPA expects site-specific consultation with Tribes on other issues related to the applica tion of this Framework typically will occur.

This Framework is not intended to repl ace government-to-government consultation on specific sites. EPA’s release of the Framework does not imply concurrence by the Tribes. Nothing in the Framework will limit, modi fy, or change Tribal treaty rights.

EPA risk assessments should include both cen tral and high-end estimates of exposure (EPA, 2000d, 2002c). Risk assessments based on Trib al fish and shellfish consumption studies with sufficient information concerning the resp onses of individual consumers should generally use the consumption rate associated with the 95th percentile of adu lt fish and shellfish consumers. The 95th percentile represents an appropriate high-end exposur e scenario, consistent
with EPA’s Risk Assessment Guidance for Superfund, Volume I, Part A (EPA, 1989).

EPA recognizes that the quantitative nature of the risk assessment process inadequately addresses the impacts of fish and shellfish chemical contamination on Tribal culture and lifeways. As part of EPA’s site-specific c onsultation, EPA will invite Tribes to provide a qualitative discussion of their perceptions as to how fish and shellfish chemical contamination
has affected them. This information would be forwarded to EPA risk managers along with the quantitative risk assessment.

An EPA Region 10 advisory inter-program revi ew group will be established to review site-specific applications of this Fr amework, as needed and appropriate.6 III. Key Considerations

For this Framework, several key factors affect the exposure parameters:

! Hierarchy of preferred data sources

! Current conditions as predic tors of future conditions

! Use of substitute fish and shellfish sources (“resource switching”)

! Use of anadromous fish data

! Use of child-specific consumption rates

! Other exposure considerations

A. Hierarchy of Preferred Data Sources

Ambient water quality criteria (AWQC) published by EPA serve as one basis for regulatory protection of surface water quality and human health. The agency’s methodology for deriving AWQC (EPA, 2000a, b) provided useful direction in the development of the
Framework.

The AWQC methodology (EPA, 2000a, b) ranks four types of consumption data, in order of preference, as refl ected in the Flow Sheet (Step 1) of the Framework:

! Fish and shellfish consumption surveys of lo cal watersheds represen tative of the people being addressed for the particular water body

! Fish and shellfish consumption surveys that reflect geograp hy and population groups
similar to those under evaluation

! National food consumption surveys

! Default values

To address the first two tiers of this hierar chy, fish and shellfish consumption surveys of Puget Sound Tribes were reviewed. Two studies, one of the Tulalip and Squaxin Island Tribes (Toy

et al , 1996) and one of the Suquamish Tribe (Suquamish Tribe, 2000) were available. For a number of reasons, EPA believes these studies were well designed. They consiste d of personal interview surveys conducted by Tribal members that elicited fish and shellfish consumption information over the course of an entire year. Participants in th e surveys reviewed for this Framework were randomly selected, providing an unbiased estimate of fish and shellfish consumption. Interviewers in the surveys were trained, enhancing the consistency and accuracy of survey administration and data recording. The surveys were pilot- tested to identify and address survey administration problems. Professional statisticians participated in survey desi gn and data analyses. Tran scription of data from paper to computer file fo rmat was quality controlled.

Though not relevant to the studies EPA is usi ng for this version of the Framework, other survey methodology types are sometimes used to estimate fish and shellfish consumption rates. Because of the issues discussed below, EPA Region 10 would prefer not to use survey data collected7 using these methods to develop Trib al fish and shellfish consumption rate estimates. Much of the following discussion is based on an EPA review of fish and wildlife surv ey methodologies (EPA, 1998c). Other types of surveys commonly employed are mail and creel surveys. Mail surveys typically are limited to reports of types and amou nts of fish caught, with no opportunity for question clarification or interviewer pr obing to obtain correct responses. Creel surveys are conducted by inspecting an angler’s catch in the field. Creel surveys have a number of issues, including: difficulties in eliciting year-round consumption informa tion; difficulties in using visual aids or other materials to assist in quantifying consumption; inab ility to obtain a random, unbiased sample of the study population; the willingness of the interviewee to provide information in a field situation when
the interviewee would rather be an gling; and problems in relating an angler’s catch to consumption rates of the angler’s family and community. Cree l surveys of Tribes typi cally are not conducted by Tribal members, which could decrease the comfort of interviewees and the probability of complete
and accurate transmission of information.

Because of the quality of the survey methodol ogy used in the available Puget Sound Tribal studies, EPA believes that these studies are appropria te to use to develop Puget-Sound harvested fish and shellfish consumption rates. Further, EP A believes that the rates developed from the aforementioned studies should be used in preference to an estimate of an average subsistence consumption rate, as recommended in the EP A AWQC methodology (EPA, 2000a,b). Site-specific factors should enter into the proc ess of selecting a consumption rate , as discussed in more detail in
Section IV of the Framework.

Where no Tribal-specific data are available fo r use, a non-Tribal fish consumption report based on nationwide studies with acceptable levels of scientific quality is Estimated Per CapitaFish Consumption in the United States (EPA, 2002a). It is of limite d value in estimating long-term consumption rates for American Indians. The consumption rates reported in the document are from the combined 1994-1996 and 1998 Continuing Survey of Food Intakes by Individuals (CSFII), conducted by the U.S. Department of Agriculture. The CSFII surveys were designed and conducted to support unbiased estimation of food consumption across the Unite d States, based on fish and shellfish consumption as reported by individuals during two non-consecutive days. EPA considers this methodology appropriate for estimating mean inta ke values of the U.S. population in general, based on fish and shellfish consumption reported by individual survey partic ipants, but because of insufficient numbers of participants in certain populations, including American Indians, the fish consumption estimates are not cons idered to be representative of such populations. In the AWQC methodology (EPA 2000a, b), EPA recommends a defau lt consumption rate for subsistence fishers, when local or regional data are unavailable. Th e 99th percentile consumption rate from the 1994- 1996 CSFII respondents who reported ea ting fish during the two-day su rvey period as well as those who reported not eating fish during th at period fell within the range of average values for subsistence fishers, based on studies available at that time. The 99th percentile c onsumption rate for this group is 215.7 g/day for all finfish and shel lfish (EPA, 2002a). This Framework recommends using this value only when no Tribal-specific data are appropriate for use.

Concerns have been expressed regarding the methodology used by EPA to establish the default AWQC subsistence fish consumption rates. In Fish Consumption and En vironmental Justice8 (EPA, 2002b), the National Environmental Justice Advisory Council (NEJAC), a federal advisory committee that provides independent advice, consultation, and recommendations to the EPA
administrator on matters related to environmental justice, took issue with the use of a fish consumption rate for Tribes that includes survey respondents who reported eating no fish during the survey period. The report could be interpreted to call for using consume r-only rates from the CSFII

surveys:

EPA’s default values are based on per capita consumption rates from the general population - that is, “fish consumption” rates that include fish consumers and fish non-consumers alike. The CSFII study on which the EPA’s defaults are based for its Draft Methodology surveyed 11,912 individuals annually for 3-day periods 3 . Of the 11,912 participants, only 3,972 actually ate fish during the three days surveyed . These were the fish consumers; their fish consumption rates were recorded. The 7,940 pa rticipants who didn't eat fish during the [survey] period were the fish nonconsumers; th eir fish consumption rates were entered as “0.” The CSFII study then generated two sets of figures: a set considering only the fish consumers and a set considering both the fish consumers and the fish nonconsumers. EPA chose to base its default values on the latter, per capita figures. Importantly, the effect of this choice is again to decrease the resulting defa ult [fish consumption rates]- with so many “zero” values factored in, the point estimates are decreased at every point of comparison. So, for example, whereas the mean value for fish consumers is 106.39 g/day, the mean
value once fish nonconsumers are also included sinks to 18.01 g/day; similarly, whereas the 99th percentile value for fish consumers is 399.26 g/day, the 99th percentile value drops to 142.96 g/day. 4

B. Current Conditions as Predictors of Future Conditions

Where Tribal members have already reduced their harvest of fish and shellfish from impaired habitat, the use of current consump tion rates could result in underestimations of potential fish and shellfish consumption rates. As noted in the NEJAC report (EPA, 2002b):

“A suppression effect occurs when a fish consumption rate for a given subpopulation reflects a current level of consumption that is artificially diminished from an appropriate baseline level of consumption for that subpopulation . . . When agencies set environmental standards using a fish co nsumption rate based upon an artificially diminished consumption level, they may set in motion a downward spiral whereby the resulting standards permit further contamination and/or depletion of the fish and aquatic

resources.”

Cleanup levels in the local aquatic environmen t, if they are based on current fish and

3 The survey period was decreased to two (non-consecutive) days as of the 1994 survey period. Previously, it was three days.

4 The value of 142.96 g/day in this quotation refers to freshwater and estuarine species only; 215.7 g/day is the comparable consumption rate that includes all fish, a combined value representing survey respondents who did and did not report eating fish on at least one day of the survey period. The 95th and 99th percentiles for survey respondents who reported eating fish on at least one day of the survey period are 333.8 and 518.7 g/day, respectively (EPA, 2002a).9 shellfish consumption rates in th e vicinity of the cleanup site, ma y not reflect the potential for the water body to rebound from its current, relatively c ontaminated state. This should be considered when deciding whether the use of a surrogate Trib al fish and shellfish consumption rate would better represent potential future consumption rates than would c onsumption rates that represent only current or near-term contam ination and habitat conditions.

C. Use of Substitute Fish and Shellfish Resources

For purposes of the Framework, if certain species or types of fish and shellfish are not present, or will not be present in the future, Tribal members are assumed to substitute other species or types of fish or shellfish that may be equally affected by the site. This assumption of “resource switching” among local fish and shellf ish is incorporated into the Framework by holding constant the total amount of fish and shellfish consumed.

The policy decision to assume that resource switching occurs is supported by limited data and examples in Puget Sound. For example, indi viduals in the Suquamish Tribe (2000) study eat “more geoduck now, because they are more available to us, but we used to dry oysters and clams....” Two other respondents reported “reduced consumption of butter clams, cockles, and other clams and shellfish due to pollution,” but that this “reduced consumption was offset by the higher availability of geoducks from the S uquamish Tribe.” Resource switching has been documented in other areas affected by contamin ation, such as Alaska (Fall and Utermohle, 1999).

The use of fisheries resources is important to Tribes for economic, dietary and cultural reasons. Tribes will likely use whatever fisherie s resources are available to them. The following observation is made in the NEJAC report (EPA, 2002b):

“For many communities of color, low-income communities, Tribes, and other indigenous peoples, there are no real alternatives to eating a nd using fish, aquatic plants, and wildlife. For members of these groups it is entirely impractical to “switch” to “substitutes” when the fish and other resources on which they rely have become contaminated. There are numerous and often insurmountable obstacles to seeking alternatives ( e.g. , fishing “elsewhere,” throwing back “undesirable” species of fish, adopting differe nt preparation methods, or substituting beef, chicken or tofu). For some, not fishing and not eating fish are unimaginable for cultural, traditional, or religious reasons. For the fishi ng peoples of the Pacific Northwest, for example, fish and fishing are necessary for survival as a people – they are vital as a matter of cultural flourishing and self-determination.”10 D. Use of Anadromous Fish Data

Salmon and other anadromous fish species are addressed separately fr om other species in this Framework. This distinction is based larg ely on differences in life cycles. [Note: steelhead, the anadromous strain of rainbow trout, are include d with salmon in the Puget Sound Tribal studies.]

Salmon

For sites in Region 10, particularly PCB-c ontaminated sediment sites, salmon have typically been excluded from the fish consumption ra te used to estimate site-related risks. This exclusion has been based on the assumption that a dult salmon spend most of their lives in the open ocean and take up bioaccumulative and persiste nt contaminants almost exclusively via the food chain in that environment. It also has been presumed that site-related chemicals are not transported to that relatively di stant aquatic environment, wher e adult salmon might be exposed to them through the food chain.

In this Framework, risks associated with th e consumption of salmon may be eliminated
from consideration as contributi ng to site-related risk s, on a site-specific and chemical-specific
basis. Factors that could be c onsidered in decisions to include or exclude risks from persistent, bioaccumulative chemicals in salmon include salmon residence time near the site; evidence that salmon harvested near the site have higher concen trations of the contaminant of concern than
salmon harvested in cleaner areas ; and the relative lik elihood that s ite-related contaminants are being transported to areas remote from the s ite, where salmon may accumulate them via the food
chain.

For site-related contaminants that are not c onsidered bioaccumulative and persistent, the potential for salmon to take up such chemicals via epithelial tissue or gill contact while present in the vicinity of the site should ge nerally be evaluated for inclusion in estimating site-related risks. Examples of other circumstances where it may be appropriate to exclude certain chemicals are provided in the Framework narrat ive and in the Flow Sheet.

Because information to fully evaluate these factors may be limited, decisions will, of necessity, be based on best professional judgment along with available, relevant scientific
information.

Other Anadromous Fish

Anadromous fish other than salmon (and steelh ead trout) that have been harvested in Puget Sound may be consumed by Tribal members (Toy et al ., 1996; Suquamish Tribe, 2000). Because these species may spend relatively more of their lives in the lo cal aquatic environment than do salmon, and because the da ta generally are not available to determine whether or not contaminant body burdens may be locally acquired, it is recomme nded that non-salmon anadromous species that commonly occur at the site be included in the assessment of site-related
risks.11 E. Inclusion of Child-Specific Consumption Rates

The Framework recommends that child exposures to site-related contaminants due to fish and shellfish consumption be included in assess ments of risks and development of media cleanup levels when the necessary data are available. Consistent with a 1997 Presidential Executive Order (The White House, 1997), EPA “shall ensure that its policies, programs, activities, and standards address disproportio nate risks to children that result from environmental health risks.”
The risk assessment results of EPA’s 1994-1996 Co lumbia River Basin fish contaminant survey demonstrated that, for Tribal members eating fi sh harvested from the Columbia River, noncancer health hazards to children were approximately twice those for adults (EPA, 2002d).

The two studies that EPA used as sources for Tribal adult consumption rates also surveyed children’s fish and shellfish consumpti on. However, there are a number of issues that
would need to be resolved before EPA would be prepared to include the Suquamish or Tulalip Tribes’ children’s consumption rate estimates in to the Framework. EPA is planning to request the assistance of the Tribes and statisticians to address these issues and will expand this Framework to include child consumption inform ation related to these Tribal studies as it
becomes available.

When adequate Tribal-specific studies for children’s consumption rates are unavailable, other options may be considered to estimate Tribal child fish and shellfish consumption rates in Puget Sound and the Strait of Georgia. Four are presented here without implying or recommending a preference. Other approaches also may be proposed for consideration. The
decision as to how best to estimate child cons umption rates should be considered on a sitespecific basis and in consultation with Tribes.

1) Fish and shellfish consumption rates are provided for age categories from ages 3 to 17 in EPA, 2002a (Section 5.1.1.1, Table 5). The 99 th percentile consumption rate of 100.5 g/day is
identified for consumer and non-consumer childre n, ages 3 to 5, in the general U.S. population. 5

2) A ratio of adult to child consumption rate s from another Tribal study could be applied to a Puget Sound Tribal- specific adult consumpt ion rate to estimate a fish and shellfish consumption rate for children. For example, usi ng data in the Columbia River Inter-Tribal Fish Commission (CRITFC, 1 994) study, the median consumption rate for consumer-only children under six years of age can be calculated to be 40% of the median consumer-only adult consumption rate from the same study. 6 This percentage could be applied to a Puget Sound

5 A higher consumption rate should be used for contaminants with reference doses based on developmental effects, when using this option. See Section VI.F. in this Framework.

6 Based on a comparison of the 50 th percentile median consumer-only adult rate with the 65 th percentile consumeronly child rate. Actual child fish consumption data were unavailable for the 50 th percentile.12 Tribal-specific adult consumption rate to estimate a fish and shellfish consumption rate for
children.

3) The fish and shellfish consumption rate fo r children ages 3 to 5 is 38.9% of the adult rate, using a comparison of mean consumption ra tes for the general U.S. population from EPA, 2002a (Section 5.1.1.1, Tables 4 and 5). This percenta ge could be applied to the adult rate used in a specific assessment to provide an estimate of children’s consumption rates.

4) Total adult consumption rates (in units of grams per day) may be used in combination with children’s body weights to assess children’s. While this would likely result in an overestimation of children’s consumption rates, it would be inappropriate to attribute adult consumption rates in terms of grams per kilogr am of body weight to children, since children generally consume more food pe r kilogram of body weight th an do adults (EPA, 2000a; EPA, 2002a).

F. Other Exposure Considerations

An assessment of estimated risks associ ated with fish and shellfish consumption must include an assumption of the number of years Tribal members obtain fish from a specific harvesting area. Tribal-specific demographics th at provide a high-end estimate of this exposure duration should be used if available. Otherwise, an assumption of 70 years, used as the standard default in Superfund and RCRA risk assessments to represent the lifetime of an individual, is recommended for use as the exposure duration when estimating Tribal risks from consuming fish and shellfish harvested in a given location.

This Framework recommends that risk assessments be performed using the weight of uncooked fish, with no modification for potential contaminant losses or gains during cooking. The use of uncooked weights is consistent with the fact that uncooked fish consumption rates
were measured in the Tribal fish and shellfis h consumption studies cited in the Framework. Furthermore, results of fish tissue analys es in Region 10 are reported as contaminant concentrations in uncooked samples.

Estimation of risks from eating fish and shellfish requires an assumption of the body weight of the consumer. This Framework reco mmends using the average body weight from the study selected for estimating the fish consumpti on rate. If body weights ot her than EPA’s default of 70 kg are used, EPA risk assessors may need to determine whether corrections to doseresponse relationships incorporated into risk cal culations are necessary on a chemical-specific
basis.13 IV. Steps for Selecting the Tribal Fish and Shellfish Consumption Rate

The following sections are to be read in c onjunction with the Flow Sheet provided with this Framework. Items in boldface type ar e quoted directly from the Flow Sheet.

Application of this Framewor k requires many site-specific de cisions and these decisions are expected to be made in consultation with the Tribe or Tribes interested in or affected by the
site. These decisions and their supporting rationale should be doc umented in writing as part of EPA’s risk assessment and risk management processes.



### Step 1: Select Basis for Tribal Fish and Shellfish Consumption Rate

The adjudicated U&A of the Tulalip Tribes extends from the Canadian border south 120 miles to the northern end of Vashon Island, en compassing areas of both Puget Sound and the Strait of Georgia. The U&A of the Suquamish Tribe encompasses waters of Puget Sound and the Strait of Georgia from the northern tip of Vashon Island to the Fras er River in Canada, including Haro and Rosario Straits, the stream s draining into the western side of Puget Sound,
and Hood Canal.

Consumption rates were derived for this Fr amework from participants in the Suquamish Tribe and Tulalip Tribes studies (Suquamish Tribe, 2000; Toy et al.

, 1996) who reported consuming shellfish or specific categories of fish that were harvested from Puget Sound. Consumption rates of fish and shellfish harv ested from Puget Sound were much higher for members of the Suquamish Tribe than for the Tulalip Tribes. A large percentage of this difference is shellfish consump tion, particularly clams. A car eful reading of the Suquamish Tribe (2000) study presents some of the cultural a nd historic basis for this difference. Extensive
shellfish habitat is found in ma ny areas of Puget Sound, including in the U&A of the Suquamish Tribe, but is uncommon in many other areas.

As part of the Framework, Region 10 reco mmends, as a policy decision, that for CERCLA and RCRA sites in Puget Sound or the St rait of Georgia with extensive intertidal habitat, the consumption rate derived by EPA from data collected by the Suquamish Tribe represents a sustainable consumpti on rate suitable for estimating si te-related risks. Again, as a policy decision, for sites in Puget Sound and the St rait of Georgia that lack extensive intertidal habitat, the consumption rate derived by EPA from data from the Tulalip Tribes represents a sustainable consumption rate. While less than fo r the Suquamish Tribe, significant quantities of shellfish are included in the total consumption rate of the Tulalip Tribes. Where a Tribal-specific survey exists, and where a cleanup site is with in that Tribe’s exclusive U&A, the fish and shellfish consumption exposure scenarios also sh ould include the consumption rate based on that
Tribe’s data.14 Box PS-1. Are Puget Sound fish and shellf ish consumption studies relevant to the Tribe(s)? (“The Tribe(s)” refers to a Tribe or Tribes whose U&A is at or near the site.)

The Puget Sound Tribal fish and shellfish c onsumption data used in this Framework are for the Tulalip Tribes (Toy et. al. , 1996) and the Suquamish Tribe ( 2000). If the answer is “no,”
move to Box PS-3. If the answer is “yes,” move to Box PS-2.

Box PS-2. Does the site or its environs have (existing or potential) high quality physical habitat to support substantial shellfis h harvest in the absence of contamination?

If the answer is “yes,” move to Box PS-6, use the consumption rate derived from data collected by the Suquamish Tribe study as a basi s for selecting the Trib al fish and shellfish consumption rate, and move to Box PS-8. If the answer is “no,” move to Box PS-5. The consumption rate derived by EPA from data from th e Tulalip Tribes may be used as the basis for the Tribal fish and shellfish consumption rate. The answer might be “no” where, for example, some intertidal habitat exists, but does not include extensive shellfish beds. Move to Box PS-8.

In addition, where a Tribal-specific survey ex ists and where a cleanup site is within the Tribe's exclusive U&A, the fish and shellfish co nsumption exposure scenarios should include the consumption rate based on that Tribe's survey data. Depending on the location of the cleanup site and other factors, this fi sh and shellfish consumption rate may not be the only consumption
rate evaluated.

The following information is provided to support the asse ssment of shellfish habitat quality. The assessment can be done by assembling existing information for the categories given below, discussing how the paramete rs affect physical habitat qualit y, and using the results of the assessment to help make the Yes/No determinatio n for Box PS-2. Because information to fully evaluate these factors may be limited, decisions will, of necessity, be based on best professional judgment along with the available rele vant scientific information, as well as oral hi story or other
information a Tribe would like to co ntribute to the evaluation. This evaluation is expected to be performed in consultation with the Tribe or Tr ibes interested in or affected by the site.

Given the wide variety of feeding, growth, and survival strategies of shellfish, high quality and quantity of shellfis h harvest relies on ma ny interacting parameters. Assessing the available information for the following can help determine whether high quality physical habitat exists (or could exist) at the si te or its environs, regardless of the presence or absence of siterelated contaminants:

• Basic characteristics Food availability – are levels of food in the water column or sediment sufficient to support high shellfish growth rates? If not, then even optim al physical substrate, temperatures, absence of predators or other factors important to survival and growth will not be good indicators of high harvest potential.15 Water quality – are the basic water quality parameters ( not related to site releases) in optimal ranges for shellfish growth? This determination will likely be species-specific.

Substrate quality – are the basic sediment parameters (not related to si te releases of contaminants) in optimal ranges for shellfish growth? This determination will be species-specific since different habitats (mudflat, sa nd, hard substrates, dredged channels, etc ., will support different species with different productivities). A second, important aspect of substrate physical quality to assess is harvestability, i.e., does the physical habitat suchas debris or soft mud affect
access to the shellfish?

• Existing shellfish quality/quantity The shellfish may or may not be a useful indi cator of high quality phys ical habitat. Sampling shellfish to evaluate condition, growth rate s, survivorship, and reproduction can provide information that integrates multiple parameters influencing shellfish productivity. If existing shellfish populations are high in quality ( e.g. , tissue mass per individual) and quantity ( e.g. , density), then it is reasonable to conclude the physical habitat is of high quality. However, if existing shellfish populations are ab sent or low in quality, then th e assessment of high quality physical habitat will rely on the ev aluation of food availability and water and sediment quality as
outlined above.

• Site context Site context is an important element in the asse ssment of high quality habitat that will support
substantial shellfish harv est in the absence of contamination. It may be useful to consider the quantity of high quality shellfish habitat with in a reasonable geogra phic area (river, bay, etc .) at or around the site. Areal estimates of existing or potential habitat could be described for the intertidal, shallow subtidal, and deeper subtidal areas. For example, in an urban river estuary, total intertidal area might be estimated as approximately 500 acres, whereas high quality
intertidal shellfish habitat is approximately 20 acres, wher eas a large bay might have 10,000
acres of shallow subtidal habitat with 9,000 estimated as high quality.

• Other considerations Additional parameters may affect the overall assessment of high quality physical habitat ( e.g. , disease, predation, competition, settlement cues, etc .).

• Existing v. potential quality It is important in the assessment to evaluate ex isting conditions and also consider whether future likely conditions could change the ph ysical habitat quality/quantity.

Table 1 describes specific examples of the above-defined parameters that may be evaluated on a site-specific basis to provide i nput to the assessment of high quali ty physical habitat for shellfish harvest. Characterizing habitat quality will ultimately depend on the species of shellfish evaluated and their tolerances for existing and potential habitat parame ters. Habitat quality should be evaluated for a variety of shellfish. Fo r example, for bivalves, several example species16 of both surface deposit feeders and suspension feeders ( e.g. , mussels, geoducks, soft-shell clams, horse clams, cockles, etc .) selected on the basis of their ecological and human health importance ( e.g. , Tribal preferences) should be included in the assessment. Th e habitat characteristics, both existing and potential (i.e., in the absence of site-related and non-si te-related contamination) at a site may then be compared with the shellfish habitat requirements.

Table 1. Characteristics for evaluating hi gh quality shellfish habitat to support substantial shellfish harvest and examples of types of parameters that can be evaluated for both existing and future conditions

Basic Characteristics – not related to site releases of contaminants Food (water column and sediment) Chlorophyll a, Total Suspe nded Solids, nutrients (NO 3 , NH 4 ) Source of food (stable isotope ratios) Water Quality Temperature range, dissolved oxygen, salinity range, pH, turbidity Sediment Quality Temperature ra nge, dissolved oxygen, salinity range (including ground water discharg es such as seeps), tidal range, organic carbon, grain size distribution (surface and at depth)

Access to harvest (debris, s hore/water access, substrate) Existing Shellfish Quality/Quantity Quality Condition index, scope for growth, survivorship, reproduction, growth rate (mm/month, growth rings,

etc .), adult size Quantity Density (#/m 2 ), recruitment, survivorship

Site Context

Context of the amount of high quality habitat For example, estimate both total intertidal area and the high quality intertidal area in a reasonable geographic area (river, bay, etc .) at or around the site. Estimates can be made for shallow subtidal and deeper subtidal areas.

Other Considerations Larval pool and settlement

cues Recruitment

Predation Density, shell indi cators (breaks, drill holes, etc .), refugia (substrate, debris, plants, etc .)Background levels of nonsite-related contaminants Tissue residues, sediment or water concentrations, fecal coliforms, PSP, Domoic acid, etc

. Competition Density and growth rates

Disease Shellfish pathology17 Box PS-3. Will there be (or has there been) a fish and shellfish consumption study conducted for the potentially affected Tribe s? A study of this nature w ould be preferred if the Tribal data used in this Framework are inappr opriate. However, because of time, cost, and information constraints, the preparation of site- and Tribe-specific fish and shellfish consumption studies is likely to be the excep tion, not the rule. In addition, ar tificially suppressed consumption rates may be present if the local aquatic e nvironment has been si gnificantly impaired by contamination. In such cases, use of a surrogate study may be preferable. If the answer is “yes,” move to Box PS-4. If the answer is “no,” move to Box PS-7.

Box PS-4. The Tribal-specific consumption st udy may be used as the basis for fish and shellfish consumption rates.

Box PS-7. The default consumption rate of 215.7 g/day (EPA, 2002a) may be used when no Tribal-specific value is available or appropriate. This is the least preferred option, consistent with the hierarchy in the AWQC Methodology (EPA, 2000a). Move to Box PS-8.

Box PS-8. Proceed to Step 2 of the Flow Sheet to select the consumption rate.



### Step 2: Select Fish and Shellfish Consumption Rate

The Puget Sound Tribal fish consumption st udies cited in this Framework include information on all fish and shellfish consumed by the surveyed Tribal members, including, for example, fish and shellfish purchased in stores or restaurants, some of which may have come from other water bodies. The studies may also re flect fish and shellfish harvested by Tribal members far from the cleanup site. To assume th at the total quantity of fish and shellfish consumed by the participants in the studies was harvested from the local aquatic environment would likely result in a significant overestimate of risks and hazards due to site-impacted fish and shellfish. To estimate the portion of cons umption rates that may be impacted by site releases, the Framework includes consumption ra tes only for fish and shellfish identified by individual survey participants as having been ha rvested from Puget Sound. All fish and shellfish identified as being obtained from grocery stores , restaurants, or loca tions outside Puget Sound were eliminated from the consumption rates pr esented herein for use in estimating risks and developing cleanup levels. (See Appendix C for further details on the method for calculating the rates in Box PS-9.)

Box PS-9. Select the fish and shellfis h consumption rates corresponding to the information source selected in Step 1.

Box PS-9 lists the 95th percen tile consumer-only consumption rates of fish and shellfish harvested from Puget Sound derived from the data collected by the two Puget Sound Tribes.
Also listed is the default value recommended wh en appropriate Tribal-specific data are not
available.18 Box PS-10. Select a mix of categories or species of fish and shellfish to reasonably represent consumption patterns, while holdin g constant the total consumption rate. This task is not necessary where only a total consumpti on rate is needed, regardless of species. Most of the data in the Puget Sound Tribal seafood co nsumption studies are available by fish types (bottom, pelagic, anadromous, a nd shellfish). (See Appendix B.)

• If a Tribe-specific consumption study is ava ilable and applicable to the site in question,
calculate the ratio of fish t ypes or species from average consumption rates, and apply
those ratios to the 95th percentile consumption rate.

• Where the consumption rate is based on th e Tulalip or Suquamish Tribal survey results, the ratios of fish types provided in Appendi x B of this Framework should generally be used. Where necessary, these values may serv e as a starting point for further decisions, for instance, the percentages of shellfish c onsumed represented by crab and by clams. If the values in Appendix B are not appropriate to a particular site, consideration should be given to adjusting these rates, based on info rmation about the types and abundance of fish and shellfish present at the site and/or info rmation provided by the affected Tribes about preferred catch.

• For sites where the general U.S. population per capita consumption rate (EPA, 2002a) is used, apply either ratios based on one of the two Puget Sound Tribal studies (if considered appropriate to the lo cal aquatic environment) or de velop ratios relevant to the affected Tribe(s). In genera l, the ratios reported in EPA (2002a) are unlikely to be relevant, because they are based on the types of fish available and consumed throughout the country.

Other assumptions about the mix of species th at constitutes the Tribal fish and shellfish diet may be used for additional risk calculations . Such analyses might focus on species or groups of species ( e.g. , those with relatively small home ranges) thought to present th e largest source of risk to Tribal members. In addition to potentially affecting remedy selection, this type of analysis can help characterize the uncertain ty or sensitivity of the calcula ted risks to assumptions about species ratios within the diet.

Box PS-11 and Box PS-12 reflect possible species-specific or contaminant-specific
modifications. A hypothetical case appl ying the information in Boxes PS-11 and PS-12 is provided in Appendix D.

Box PS-11. Salmon.

A decision must be made to include or excl ude risks associated with consumption of salmon on a site-specific and contaminant-specif ic basis. See Section III.D for examples of factors to consider when making this decision, Section V for associated uncertainties, and Box
PS-12 for other considerations.Box PS-12. Additional contaminant and aquatic life issues.

This step may be used in consultation w ith a fish biologist or other expert to determine whether it is appropriate to redu ce estimates of site-related risks due to consumption of fish. A contaminant may be eliminated from consideration for certain species or groups of species if sufficient evidence demonstrates that it does not accumulate or is not otherwise present in the tissue when harvested; that it is present but
from a source other than the clea nup site; or that it is presen t but not of concern to human health. Examples of such evidence may incl ude but are not limited to the following:

• Residence time in the vicinity of the site precluding more than de minimis uptake of the contaminant into tissue of the fish type being evaluated

• Adequate sampling/chemical analysis dem onstrating that a contaminant is absent from tissue, using analytical methods sufficiently capable of detecting
concentrations of concern to the maximum degree practicable

• Scientific literature prov iding significant evidence th at the contaminant as found
in fish is not of concern for human health

• Modeling of the contaminant demonstra ting no significant bio-concentration or
bioaccumulation in tissue of the relevant ca tegory or species of fish, regardless of residence time in the local aquatic environment

• Metabolism in the organism rendering th e contaminant of no concern to human health upon consumption of the fish

• K
ow /water solubility characteristics substantially limiting uptake of the
contaminant into tissue of the fish.

For discussions of some of these i ssues, see Barnhard (2003), Roose and Blindman (2000) and Hall (2002).

V. Selection of Species for Collect ion of Chemical Contaminant Data and Derivation of Exposure Point Concentrations

A. Selection of species for collec tion of chemical contaminant data

In preparing to collect contaminant data for aquatic biota that may be affected by site- specific contamination
, considerations in determining which species should be analyzed for contaminants should include:

• Which species are most co mmonly consumed by Tribal members;

Page 19• Which species may have the highest levels of contamination ( e.g. , predators, bottom feeding species);

• Area fidelity of species: species that tend to stay in a specific area are more likely to be impacted by site-related contaminants than are species with large home ranges;

• Relative abundance of a species; and

• Which species may have the highest lipid content; species with higher fat-containing tissue are likely to have hi gher wet weight contaminant concentrations of lipophilic
contaminants.

. B. Derivation of exposure point con centrations when data for multiple species are available.

When chemical contaminant concentrat ions are available for multiple species within a species group (i.e., benthic, pelagic, shellfish, anadromous. etc .), the question
arises as to how to utilize these data to derive an overall species group contaminant concentration for computation of total contaminant dose and c onsequent risks. There are a number of ways by which this issue could be addressed. The site-s pecific approach is expected to be selected in c onsultation with the Tribe or Trib es interested in or affected by the site. Approaches may include:

1. Weighting contribution of individual species contaminant concentrations on the basis of species-specific consumpt ion rates from seafood consumption

surveys.

When species-specific consumption rate s and contaminant concentrations are available, those consumption rates ma y be used to develop a weighted contaminant concentration for that species group. Average consumption rates are based on consumption of a species regardless of source ( e.g. harvested, purchased in grocery stores, consumed in restaura nts) and would be obt ained from either published study results or by analyzing th e data associated with a study. The equation for computing a weighted speci es group concentration is as follows:

C weighted = C 1 x (IR 1 / Σ IR) + C 2 x (IR 2 / Σ IR) + ... + C

n x (IR

n / Σ IR)

Where:

C weighted = the weighted contaminant c oncentration for the species group

C 1 , C 2 ,...C
n = 95% upper confidence level (UCL) on the mean contaminant concentrations for individual sp ecies within the species group (an estimate of the true average concentration);

IR 1 , IR 2 ,...IR
n = average ingestion rates for individual species within the spec ies group regardless of fish and shellfish source; and

Page 20Σ IR = the sum of the average ingestion rates for all species for which chemical
contaminant data are available

In some instances, there may be data on a species that is representative of more than one species within a species group. This is particularly likely for shellfish. For example, concentration data for a single sp ecies of clam may be used to represent contaminant concentrations in all bivalves; concentration data from a single species of crab may be used to represent contaminant con centrations in all crabs. In cases where a species may be representative of multiple sp ecies within a species group, the combined ingestion rate for these multiple species s hould be used to develop the weighted concentration rather than the consumption rate of the individual species. For example, if data were available for a bivalve species a nd a crab species, the weighted concentration would be computed using: the 95% UC L species-specific bivalve contaminant concentration, the average consumption rate for all bivalves, the 95% UCL speciesspecific crab contaminant concentration, and the average consumption rate of all crab species.

2. Weighting contaminant concentrations ba sed on best professional judgment. Such weighting factors may include the following considerations:

• Average 95% UCLs for all species: The average of the 95% UCL concentrations for all species could be used for the species group concentration.

• Use of the highest concentration: The entire species group concentration could be based on the highest 95% UCL concentration obtained for an individual species.

• Development of weighting factors based on th e relative biomass of the different species: This approach assumes that consump tion is directly proportional to the availability of different species.

It may be helpful to employ several of these approaches to characterize the uncertainty contributed by a l ack of knowledge of the consumption rates for different species within a species group. The site-specific approach is expected to be selected in
consultation with the Tribe or Tribes inte rested in or affect ed by the site.

Page 21VI. Uncertainties

To promote transparency, EPA risk char acterizations associated with risk assessment and the derivation of cleanup leve ls should include a statement of relative confidence and protectiveness. All major uncertainties should be identified, along with commentary regarding their influence on th e assessment, consistent with agency guidance (EPA, 1989, 2000d). All un certainties inherent in th is Framework, as presented below, should also be described. The de gree to which this Framework provides a protective estimate of exposure to contamina tion from consumption of fish will depend upon the choices made in its implementation.

A. Use of a Tribal-specific fish and shellfish consumption study as a surrogate for another Tribe’s consumption rate

The use of consumption rates of Puget S ound-harvested fish and shellfish derived using Tulalip and Suquamish Tribal data as a surrogate for another Tribe in Puget Sound or the Strait of Georgia could lead to either an overestima te or an underestimate of the
actual fish and shellfish consum ption rate potentially associated with site releases. For many reasons ( e.g. cultural practices, treaty rights, types and quantities of seafood species available), Tribes surveyed in local fish and shellfish consumption studies may eat different quantities and ratios of fish and shellfish than do those who harvest near a cleanup site. Habitat quality and thus the qua ntity of fish and sh ellfish available for sustainable harvest may also be different. If the surrogate study is based on fish and shellfish habitat of higher qua lity and greater sustainable harvest capacity than would ever be possible for the water body under evalua tion, use of the surrogate data could lead to an overestimate of risks at the site. There is also the possibility that the Tribe affected by site-related releases may have higher quality resources than the study Tribe, in which case consumption rates may be underestimated. The development of additional appropriately designed and conducted Tribal consumption studies in Puget Sound and in the Strait of Georgia would contribute to the reduction of these uncertainties.

B. Degree to which traditional lifew ays or subsistence fish and shellfish consumers are included in existing Tribal consumption studies

The studies for the Suquamish and Tulalip Tribes did not attempt to quantify or otherwise distinguish fish and shellfish c onsumption for Tribal members who consider
themselves to be subsistence consumers or who practice traditi onal lifeways, although fish and shellfish consumption rates for some individuals who fall into these categories are almost certainly included in the studies . Without a Tribal-specific definition of subsistence fish and shellfish consumption and without data on th e subsistence use of areas affected by the cleanup site, it is difficult to dete rmine the degree to which subsistence consumers are protected by the consumption rates recommended in this
Framework.

Page 22C. Percentage of consumed fish and shellfish assumed to be adversely affected by site-related contamination

For purposes of this Framework, consum ption rates for fish and shellfish harvested only from Puget Sound were deri ved from the Tulalip and Suquamish Tribal data, for use in determining the amounts of consumed fish and shellfish that may be impacted by a cleanup site located in Puge t Sound. This Framework also recommends
the use of these studies to de rive consumption rates for a Tribe potentially affected by cleanup sites in the Strait of Ge orgia, on a site-specific basis. The quantities of fish and shellfish identified in the surveys as having b een obtained in restaura nts or grocery stores or harvested from areas outside Puget Sound were excluded from the consumption rates, for purposes of estimating risks th at could be associated with s ite releases. If none of the Tribal study consumption rates is determined to be appropriate for a particular cleanup site or Tribe, and the default consumption rate is used, no downward adjustment of the
total fish and shellfish c onsumption rate is recommended in this Framework.

Although the degree to which si te-related risks could be overestimated by the use of any of the fish and shellfish consumption rates presented in this Framework cannot be known precisely, these methods are preferable to alternatives that would be likely to
underestimate site-related risk s, such as basing a consum ption rate (or site-related estimates of risk) on the si ze of the cleanup site, or reducing the site’s estimated contribution to fish and shellfish contamination because nearby sites or sources are
associated with similar contaminants. This Framework includes the assumption that the selected Tribal fish and shellfish consumpti on rates and their associated risk estimates
will not be reduced based on consideration of the size of the cleanup site or the presence
of additional sources of contamination.

The use of a consumption rate based on a ll fish and shellfish harvested from Puget Sound as a surrogate for a consumption rate based on fish and shellfish affected by a cleanup site is likely to overestimate the risk of eating fish and shellfish from the site, since only a portion of the fish and shellfish diet will have actually come from the site in question. The degree of overestimation depends upon such factors as size and location of the site, type and degree of contamination, and habits of affected fish and shellfish. On the other hand, some of the fish and shellfish consumed in restaurants or obtained in grocery stores may have been harvested in Puget Sound, which could lead to an underestimate of exposure.

D. Exclusion or inclusion of risks a ssociated with salmon consumption on contaminant-specific basis

This Framework allows exclusion of risk s associated with salmon consumption if warranted by site-specific and chemical-specifi c circumstances, particularly for persistent
and bio-accumulative contaminants. Some of the uncertainties in this exclusion arise from the degree of historical contaminant transport offsite and from salmon residence
time near the site.

Page 23PCBs and other bio-accumulative and persis tent chemicals found in contaminated
sediments can be moved from their site of release via erosion, dr edging, tidal currents, flood events, and vapor transport. Offsite transport is also possible when aquatic organisms become contaminated near a cleanup site and then migrate to distant locations, where they contribute to food chain effects that eventually affect fish, including adult salmon. However, adult salmon body burdens of bio-accumulative and persistent contaminants typically come from many s ources and cannot currently be apportioned with confidence to specific locations. An assumption that contaminants present in
harvested salmon are not associated with the site, even when the same chemicals have been released from the site, is likely to undere stimate the site’s cont ribution to risks from consuming such fish. The degree of underestimati on is not known.

If the full body burden of bio-accumulative and persistent contaminants released at a site and found in local salmon is attributed to a single source ( i.e. , the site under evaluation), site contributions to risk are likely to be overe stimated, since some portion of the body burden likely has been acquired elsewhere.

Some site-related contaminants may bi o-concentrate in adult salmon due to epithelial tissue or gill cont act, depending in part upon the salmon residence time in the vicinity of the site-related contamination. Making an assumption that adult salmon do not reside in the vicinity of the site lo ng enough for bio-concentration to occur could

result in an erroneous exclus ion of contaminants in salmon from the site-related risk assessment. An assumption that bio-concentration does occur could lead to an overestimation of risks if uptake does not occur.

E. Use of the National Fish and Shellf ish Consumption Rate to Characterize

Tribal Consumption

The fish and shellfish consumption rate of 215.7 g/day from Estimated Per Capita Fish Consumption in the United States (EPA, 2002a) is a high-end (99th percentile) estimate of total fish and shellfish consump tion for the general U.S. population, including both people who consume fish and shellfish a nd those who do not. It is identified as an appropriate value to represent an average subsistence consumption rate (EPA, 2000b). Its use is recommended in this Framework as a default Tribal consumption estimate when relevant Tribal-specific studi es are not available.

EPA’s preference and general practice is to use the 95th percentile consumption rate for purposes of estimating risks to a given popul ation, when that information is available (EPA, 1989). Use of the default consumpti on rate of 215.7 g/day may either over- or underestimate the actual 95th percen tile consumption rate of fish and shellfish of the Tribal population being evaluated. Using consumer-onl y consumption rates would be expected to overestimate the consumption rate of the general population, but it may not result in overestimates for populations that consume seafood on virtually a daily basis.

Page 24F. Special Considerations of Vulnerable Individuals and Exposures to Chemicals with Selective Endpoint

Many of EPA's risk assessments and cleanup le vels for the protection of human health are based on estimated carcinogenic and noncance r adverse effects. No t all effects can be quantified, due to scientific limitations concer ning dose-response e ffects, exposures to multiple chemicals, and factors such as individua l variability. As a result, for example, for contaminants such as methyl mercury that have reference doses based on developmental effects, EPA’s AWQC methodology (EPA 2000a) r ecommends that higher fish consumption

rates be assumed for children and for women of child-bearing age, when using fish and shellfish consumption rates that are based on consumers and non-consumers, such as the default recommended in this Framework. (See S ections III.A and III.E of this Framework for discussions of default rates.) Under these circumstances, the AWQC methodology recommends that consumption rates be based on data for consumers only 7 , as differentiated from the AWQC recommendation to use consumption rates based on both consumers and nonconsumers for other population groups (EPA, 1998b; 2000a). This is an acknowledgment of the potentially increased se nsitivity of certain segments of the general population to chemical-specific effects.

Chemicals that cause human developmental, neurotoxic, endocrine -disruption or other adverse effects at potentially lo wer concentration than reflected by reference doses or other indicators of safe exposure levels, may affect individuals within a population differently. Within a Tribal community, individuals who ma y have increased vulnera bilities to potentially

toxic chemicals include “elders , pregnant women, young children, persons who are ill, and individuals who have compromi sed immune systems or limited liver and kidney function” (Arquette et al ., 2002).

Decision documents for risk assessment a nd cleanup level development should include

discussions of uncertainties in risk characterization associat ed with fish and shellfish consumption. Where appropriate, such discussi ons should include potenti al site-related risks that are not quantifiable, such as for hea lth effects not addresse d by chemical-specific reference doses or cancer potency factors, and the presence of exposed individuals within a population who may be more susceptible than those for whom risks are quantitatively

estimated. For site-related contaminants in fish and shellfish that have reference doses based on developmental effects, or for early-life exposure to carcinogens, current EPA guidance on

the assessment of risk and associated uncertainty should be consulted.

G. Use of Uncooked Fish a nd Shellfish Rates as Represen tative of Weight of Fish

and Shellfish Consumed

Because of the many ways in which fish may be served, quantitative assumptions regarding preparation methods and their eff ects on contaminant con centrations would be unreliable. Depending upon the preparation an d cooking procedures, and upon the nature of

7 See Section 5.2.1.1 Tables 3 and 5 in EPA, 2002a.

Page 25the contaminants in the fish, concentrations may decrease or increase (EPA, 1998a). For fatsoluble compounds such as PCBs, trimming and removing adipose tissue reduces the mass of contaminants in the consumed por tion of the fish. Similarly, broi ling, frying, or grilling fish is likely to result in reductions of fat-soluble compounds (Sherer and Price, 1993). Cooking is not likely to change the level of exposure to mercury because it is bound to muscle tissue and is not lost by cooking, which mostly removes moisture and fat (Morgan et al. , 1997). Fish cooked with no prior preparation, as in a stew, might show neg ligible loss of contaminants, except perhaps for volatile contaminants. Because lead concentrates in bones, preparations where bones are discarded are likely to re sult in reductions in lead exposure (Ay et al. , 1999).

H. Use of An Exposure Duration of 70 Years

A 70-year exposure period, that is, the number of years a Tribal member is expected to consume fish and shellfish from a specific harv esting area, is encouraged in this Framework where Tribal specific demographic data are not available. Risks and hazards will be

overestimated for Tribal members who obtain fi sh and shellfish from the harvest area for fewer than 70 years, but underestimated fo r those exposed for more than 70 years.

Uncertainties associated with such surrogate values shoul d be discussed in the risk characterization document, including any a ssumptions made regarding future exposure

durations.

I. Assumption that Resource Switching Occurs

If certain types of fish or shellfish preferred by Tribal me mbers are not present in their U&A, this Framework assumes that Tribal members will substitute alternative local types of fish or shellfish in their diets, generally within the same category of fish or shellfish. Thus, the total consumption rate remains the same, regardless of the availability of a particular type of fish or shellfish. This is a reasonable and pr otective assumption for Tribal members who, for economic, ceremonial, religious, or personal prefer ence reasons, are likely to substitute one species for another. The assumption that resource s will be switched is likely to result in an

overestimate of risks for other Tribal memb ers who may decrease their overall fish and shellfish consumption rate because their pref erred types are unavailable. Risks may be underestimated if the actual dietary practices of a Tribe would result in consumption of species that have higher contaminant levels than the preferred or assu med types of fish or

shellfish.

J. Exposure to Contaminants in Fish and Shellfish Other Than by Consumption

To the extent that Tribal members are e xposed by methods other than consumption and these exposure pathways can be identified, such exposure should be incorporated into a risk assessment, even if only qualitatively. Ex amples are use of bones as whistles and use of fish fat as a basis for skin paints. Omissi on of these potential e xposures may underestimate risks and hazards, but to an unknown degree.

Page 26K. Potential Overestimation of Bottom and Pelagic Fish Consumption in the Suquamish Study

Some of the bottom and pelagic fish in cluded in the Suquamish study as being harvested from Puget Sound were harvested in the Strait of Juan de Fuca. Assuming that these fish are harvested in Puget Sound, and including them in th e Framework, may overestimate

hazards and risks due to site-related c ontamination, although the degree of such

overestimation is unknown.

L. Uncertainty in Developing Weighted Species Group Concentrations in

Situations Where Data on Mult iple Species are Available

Weighted species group contaminant concentr ations (Section V) may be overestimated if the EPA derived consumption rates for species with higher contaminant concentrations are greater for the Suquamish or Tulalip Tribes than the consumption rate for these species for the Tribe or Tribes affected by a site. Conversel y, species group contaminant concentrations may be underestimated if the consumption rates for species with higher contaminant concentrations are greater for the affected Trib e or Tribes than for the EPA de rived consumption rate for the Suquamish or Tulalip Tribes.

VII. Risk Communication and Risk Management Issues

The following risk communication and risk management ideas may be useful for project managers to consider when imple menting this Framework at RCRA and CERCLA cleanup sites.

As much as possible, the risk assessment should include a descri ption of consumption rates in terms that are meaningf ul to the intended audience ( e.g. , number of 8-oz meals per week, number of pounds per week). A consumpti on rate of 32.4 g/day is equivalent to onehalf pound of fish and shellfish per week; 143 g/day is equivalent to 4.4 – one-half pound meals of fish and shellfish per week or an aver age of 2.2 lbs per week. The terms to describe consumption rates should be d ecided on a case-by-case basis.

Once it is determined that action is necessary to protect human health, site managers should consider including at least one remedial alternative that coul d reduce the excess cancer risk to the most protective end of EPA’s acceptable risk range, using exposure rates selected under this Framework. Even if not practicable to implement, such an alternative would provide a point of comparison for risk management decisions.

The effect of the assumptions on the potenti al for over- or underestimating risk is an important aspect of EPA’s risk management and cleanup decisions. All discussions and presentations about risk should clearly desc ribe assumptions and uncertainties in the

characterization of risk. One format that may be useful for EPA’s risk management

Page 27discussions is the table presen ted in Part A, Exhibit 6-21 of EPA’s (1989) risk assessment guidance for Superfund. This table lists each a ssumption or factor producing the uncertainty and its potential to over- or underestimate exposure.

VIII. Five-Year Review Considerations

Based on EPA’s knowledge of sediment clean-up sites in Puget Sound, the Framework may have limited application fo r those CERCLA and RCRA sites where the remedy has already been selected.

After a remedy has been selected, CERCL A requires that five-year reviews be conducted at any remedial action site that doe s not allow for unlimited use or unrestricted exposure. The purpose of the five-year review is to assure that human health and the environment will be protected by the remedial action.

As part of the five-year review process, Tribes can provide new information to be considered or request that the lead federal agency evaluate particular aspects of a remedy relative to Tribal interests. Such requests are most helpful when provided to the lead federal agency early in the five-year review process. Such requests would be evaluated on a site-specific basis and consistent with EPA’s five-year review guidance. EPA would generally discuss the appropria te means for addressing a Tribe’s concern with the Tribe during the review process.

While a CERCLA five-year review includes considering new information, such as new information regarding exposure rates and assumptions, it is important to keep in mind that remedies and cleanup levels at CE RCLA sites are determined by many factors. In determining whether a recalc ulation of site risks or any other detailed analysis is needed as part of the five-year review, EPA would review the basis of the selection of the remedial action and cleanup levels and other relevant information to determine whether further analysis of such updated informati on is appropriate, and focus our analysis on matters that would help assess the pr otectiveness of the selected remedy.

It is important to note that even when a five-year review recommends that a remedy change be considered, such a ch ange would happen through a CERCLA decision process. This process woul d require a ROD Amendment or Explanation of Significant Differences, not just a five-year review repor t, and would include consideration of the NCP’s nine criteria. Such changes would include consultation with the affected Tribes and would be subject to appropriate public review.

The RCRA program does not have an equiva lent five-year review process. For RCRA corrective actions being conducted as pa rt of an operating or post-closure permit, a new permit must be applied for prior to ex piration of the current permit (typically every 10 years). The selected clean-up standard s and selected remedy would be reviewed during the permit renewal to assure that the new permit is based upon currently applicable standards and regulations.

Page 28EPA acknowledges that a Tribe’s interest in or need for public health related information, such as data about existing or residual health risks to Tribal populations, may be better served outside the five-year review. EPA is available to work with Tribes interested in this type of information.

Page 29IX. References

Arquette, M., M. Cole, K. Cook, B. LaFrance, M. Peters, J. Ransom, E. Sargent, V. Smoke

and A. Stairs. 2002. Holistic Risk-Based Environmental Decision Making: A Native Perspective. Environmental Health Pers pectives Supplements, 110(S2). April.

Ay, O., M. Kalay, L. Tamer and M. Canli. 1999. Copper and lead accumulation in tissues of a freshwater fish Tilapia zillii and its eff ects on the branchial Na, K-ATPase activity.

Bulletin of Environmental Cont amination & Toxicology, 62: 160-168.

Barnhard, Lawrence P. 2003. Factors influencing the design of bioaccumulation factor and

biota-sediment accumulation factor field studies. Environmental Toxicology and Chemistry 22(2): 351-360.

CRITFC (Columbia River Inter-Tribal Fish Commission). 1994. A Fish Consumption Survey of the Umatilla, Nez Perce, Yakama and Warm Springs Tribes of the Columbia

River Basin. CRITFC Technical Report No. 94-3. Portland, Oregon.

EPA. 1989. Risk Assessment Guidance for Supe rfund. Volume I: Human Health Evaluation Manual (Part A). EPA/540/1-89/002. December. http://www.epa.gov/superfund/programs/risk/ragsa/

EPA. 1998a. Methodology for Assessing Health Ri sks Associated with Multiple Pathways of Exposure to Combustor Emissions . Chapter 8. EPA 600/R-98/137.

EPA. 1998b. Ambient Water Quality Crit eria Derivation Met hodology Human Health Technical Support Document. Final Draft. EPA/822/B-98/005. July. http://www.epa.gov/waterscience/humanhealth/awqc-tsd.pdf

EPA. 1998c. Guidance for Conducting Fish and Wildlife Consumption Surveys.

EPA-823-B-98-007. November.

EPA. 2000a. Methodology for Deriving Ambient Wa ter Quality Criteria for the Protection of Human Health (2000). Office of Water. EPA-822-B-00-004. http://www.epa.gov/waterscience/humanhealth/method

EPA. 2000b. Revisions to the Methodology for Deriving Ambient Water Quality Criteria for

the Protection of Human H ealth (2000); Notice. 65 Fed.Reg. 66,444. November 3. http://www.epa.gov/fedrgstr/EPA-WATER/2000/November/Day-03/w27924.htm

EPA. 2000c. Guidance for Assessing Chemical Cont aminant Data for Use In Fish Advisories.

Volume 2: Risk Assessment and Fish Consumption Limits - Third Edition. http://www.epa.gov/ost/fish advice/volume2/index.html

Page 30EPA. 2000d. Risk Character ization Handbook. Science Polic y Council. EPA 100-B-00-002.

December. http://www.epa.gov/OSP/spc/rchandbk.pdf

EPA. 2001. U.S. Environmental Protection Agen cy - Region 10 - Tribal Consultation

Framework. http://yosemite.epa.gov/r10/Trib al.NSF/0/4e239b01fbabd5198825694b00041cc5?OpenDo

cument

EPA. 2002a. Estimated Per Capita Fish C onsumption in the Unite d States EPA-821-C-02- 003. August 2002. http://www.epa.gov/waterscience/fish/consumption_report.pdf

EPA. 2002b. Fish Consumption and Environmenta l Justice. National Environmental Justice Advisory Council. November. http://www.epa.gov/compliance/resources/ publications/ej/fish_c onsump_report_1102.pdf

EPA. 2002c. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency (Information Quality Guidelines). EPA/260R-02-008. October. http://www.epa.gov/oei/qualitygui delines/EPA_OEI_IQG_FINAL_10-2002.pdf

EPA, 2002d. Columbia River Ba sin Fish Contaminant Survey. EPA 910-R-02-006. August. http://yosemite.epa.gov/R10/OEA.NSF/Reports/Reports

Fall, James A., and C.J. Utermohle, compilers. 1999. Subsistence Service Update: Subsistence Harvests and Uses in Eight Communities Ten Years After the Exxon Valdez Oil Spill. Exxon Valdez Oil Spill Rest oration Project Final Re port (Restoration Project 99471). Technical Paper No. 252. Alaska Depart ment of Fish and Game, Division of

Subsistence. http://www.subsistence.adf g.state.ak.us/TechPap/tp252.pdf

Hall, Jason E. 2002. Bio-concentration, bioa ccumulation, and bio-ma gnification in Puget Sound biota: assessing the ecological risk of chemical contaminants in Puget Sound. Journal on the Environment, Volume 1. http://courses.washingt on.edu/uwtjoe/toc.html

Kissinger, Lon. 2005. Development of Tulalip Tr ibes’ Fish and Shellfish Consumption Rates for Puget Sound Tribal Seafood Risk Analysis , Based on Individual Interview Results.

Internal EPA memorandum. March 9.

Morgan, J.N., M.R. Berry, and R.L. Graves . 1997. Effects of commonly used cooking practices on total mercury concentration in fi sh and their impact on exposure assessments. Journal of Exposure Analysis and En vironmental Epidemiology, 7: 119-133.

Page 31National Congress of American Indians. 2004. Use of Tribal Fish Consumption Rates by the Environmental Protection Agency. Resolution #MOH-04-023. June 23. http://www.ncai.org/data/doc s/resolution/midyear2004/04-023.pdf

O'Neill, S.M., J.E. West and J.C. Hoeman. 1998. Spatial trends in the concentration of polychlorinated biphenyls (PCBs) in Ch inook (Oncorhynchus tshawtscha) and Coho salmon (O. Kisutch) in Puget Sound and factor s affecting PCB accumulation: results from the Puget Sound ambient monitoring program. Pages 312-328 in E.R. Strickland, editor. Puget Sound Research ‘98 Proceedings. Puget Sound Water Quality Action Team, Seattle, WA. http://www.psat.wa.gov/Publicati ons/98_proceedings/pdfs/2b_oneill.pdf

Roose, P. and U. Blindman. 2000. Volatile or ganic compounds in various marine organisms

from the southern North Sea. Ma rine Pollution Bulletin 40(12):1167-1177.

See also http://www.vliz.be/Vmdcdata/imis2/person.php?show=html&persid=701

Sechena, R., C. Nakano, S. Liao, N. Polissar, R. Lorenzana, S. Truong, and R. Fenske. 1999. Asian and Pacific Islander Seafood Consumption Study in King County, Washington. EPA 910/R-99-003, May. http://www.epa.gov/r10earth/offices/oea/risk/a&pi.pdf

Sherer, R.A. and P.S. Price. 1993. The effect of cooking processes on PCB levels in edible fish tissue. Quality Assurance: Good Pr actice, Regulation and Law, 2(4): 396-407.

The Suquamish Tribe. 2000. Fish Consumption Su rvey of the Suquamish Indian Tribe of The Port Madison Indian Reservation, Puget Sound Region. August.

The Suquamish Tribe. 2007. Selected Suquami sh Tribe Seafood Ingestion Rates, Consumers Only. June 29. Prepared by Nayak Poli ssar, Ph.D. and Shiquan Liao, Ph.D.

Toy, K.A., N.L. Polissar, S. Liao, and G.D. M ittelstaedt. 1996. A Fish Consumption Survey of the Tulalip and Squaxin Island Tribes of the Puget Sound Region. Tulalip Tribes, Department of Environment, Marysville, WA.

Washington Department of Health. 2001. Health Consultation. Evaluation of Cadmium, Lead and Zinc Contamination in Spokane River Fish, Spokane, Spokane County, Washington, August 21.

The White House. 1997. Executive Order 13045. Protection of Children From Environmental Health Risks and Safety Risks. 62 Fed. Reg. 19,883. April 23. http://www.epa.gov/fedrgstr/eo/eo13045.htm

Page 32Appendix A

Development of the Framework for Select ing and Using Tribal Fish and Shellfish

Consumption Rates for Risk-Based D ecision Making at CERCLA and RCRA Cleanup Sites in Puget Sound and the Strait of Georgia

This document presents a conceptual Fr amework for a consistent approach for selecting and using Tribal fish and shellfish consumption rates for purposes of estimating
site-related risks at U.S. Environmental Protection Agency (EPA) hazardous waste cleanup sites in Puget Sound and the portion of the Strait of Georgia that is within the United States. The decision to develop this Framework to support EPA Region 10
RCRA and CERCLA risk-based decision ma king was made in 2003 by an executive team representing EPA Region 10’s Of fices of Environmental Assessment; Environmental Cleanup; Air, Waste and Toxics; and Ecosys tems, Tribal and Public Affairs. Professionals repres enting each of the first three offices were selected to be responsible to prepare a draft of the Framework, with the assi stance of their colleagues as appropriate. Remedial project managers, permit writers, human health risk assessors, senior policy analysts and managers were among those representing Region 10 who
contributed to this document.

The Framework was developed to be consistent with the following:

1) EPA’s overarching mission to protect human health and to safeguard the natural environment upon which life depends;

2) EPA Region 10’s commitment to protecting human health and the environment throughout the Region, including the lands a nd resources of Indian Tribes, while supporting Tribal self-government, fulfilli ng the federal trust responsibility, and strengthening the government to government relationship between the Tribes of our Region and EPA; and

3) "Guidelines for Ensuring and Maximi zing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by th e Environmental Protection Agency" (EPA, 2002e).

Selection and acquisition of Tribal survey data for incorporation into the Framework

Two seafood consumption surveys that assess Tribal seafood consumption in Puget Sound and the Strait of Georgia were us ed by EPA in developing this Framework. Section III A. discusses methodological strengt hs of these surveys and why EPA chose to use the surveys. These surveys are the Suqua mish Tribe (2000) survey, which addresses Suquamish Tribe seafood consumption, and the Toy et al. (1996) study, which addresses seafood consumption of the Squaxin Island and Tulalip Tribes.

Appendix A - 1The data as summarized in the Suquamish Tribe (2000) and Toy et al . (1996) study reports were not adequate to meet th e needs of the Framework in that published survey results did not provide consump tion rates for seafood harvested from Puget Sound. The need for this formulation of consumption rates derived from a policy
decision that the fraction of seafood affected by site-specific contamination would be defined as the fraction of seafood harvested from Puget Sound. Rationale for this policy decision is provided in section VI.C. of the Framework.

The methodology used to compute consumption rates of seafood harvested from Puget Sound is provided in Appendix B. EPA initially analyzed the Toy et al . (1996) data on both the Tulalip and Squaxin Island Tribes. Permission to use the original data from the Toy et al . (1996) study was received fr om the Tulalip Tribes. Dr. Shiquan Liao, a statistician involved in data analysis for both the Toy et al. (1996) and Suquamish Tribe (2000) studi es, was custodian of the Toy et al. (1996) data and transmitted data for both the Tulalip and Squaxin Island Tribe data to EPA. In consultations with the Squaxin Island Tribe, it was later determined that the Tulalip Tribes’ permission to use the Toy et al . (1996) data did not in clude use of Squaxin Island Tribe data. Squaxin Island Tribe data analysis results in cluded in an earlier
draft of the Framework were subsequently withdrawn. EPA and the Squaxin Island Tribe reached the understanding that both pa rties would continue to discuss the potential use of the Squaxin Island Tribe’s da ta in a later version of the Framework.

The Suquamish Tribe data were not anal yzed by EPA but rather by Dr. Liao, as the Suquamish Tribe has chosen to retain cu stody of its data. EPA explained the need for this data analysis to the Suquamish Tribe environmental staff, who then gave permission to Dr. Liao to conduct his analys is and transmit the re sults to EPA. Dr. Liao’s analysis was used to support the S uquamish Tribe consumption rate used in
this Framework.

During the development of the Framework, national EPA guidance and policies were reviewed, as were histor ic Region 10 site-specific approaches to the selection of fish and shellfish consumption rates for cleanup sites.

Review of the draft Framework

The initial draft Framework underwent ex tensive internal review by staff and managers within the participating offices, th e Office of Ecosystems, Tribal and Public Affairs, and by the Senior Tribal Policy Advisor. After incorporating numerous changes based on review comments, in D ecember 2004 the draft Framework was sent to the chairpersons of all the federally-recognized Tr ibes in Puget Sound and the Strait of Georgia, listed below. Copies of the letter and Framework were also sent to

Appendix A - 2an environmental director or staff pers on at each Tribe, based on information collected during a phone call to each Tribe.

Jamestown S'Klallam Tribe Port Gamble S'Klallam Tribe
Muckleshoot Tribe Chehalis Tribe Swinomish Tribe Suquamish Tribe
Lower Elwha Klallam Tribe Nooksack Tribe
Suak-Suaittle Tribe Lummi Nation
Makah Tribe Samish Indian Tribe Stillaquamish Tribe Skokomish Tribe Tulalip Tribes Nisqually Tribe Puyallup Tribal Council Yakama Nation Squaxin Island Tribe Upper Skagit Tribe Snoqualmie Tribal Council

The Tribes were asked to participate in a dialogue on the draft Framework, and meetings between EPA and individual or multip le Tribes were encouraged. EPA invited
the Tribes named above to an initial c onference call on January 11, 2005, to present the draft Framework and discuss the anticipated process for meetings and the submittal of comments. EPA met with the Water Qua lity Group of the NW Indian Fisheries Commission on February 2, 2005 and Septembe r 9, 2005, and with the Suquamish Tribe on December 6 and December 15, 2005. In Ma rch 2005, a Web-based "QuickPlace" was set up by EPA to facilitate dialogue among Tr ibes and with EPA regarding the draft
Framework. Oral or written comm ents additionally were received from four Tribes As a
result of these comments and conversations , EPA made numerous additional changes to be responsive to comments from these Tribes and sent revised versions of the draft Framework to all the Tribal chairpersons w ith copies to their natural resource or environmental director or staff pe rson on March 23, 2005, October 11, 2005, and February 22, 2006.

The draft Framework went through more ex tensive internal reviews and revisions, resulting in a draft final version, which was transmitted to all the Tribes in March 2006. The proposed changes were also presented to the Water Quality Group of the NW Indian
Fisheries Commission in June 2006. EPA con tinued to work with the Suquamish Tribe during the summer of 2006 in order to addres s its concerns. Several elements of the
Framework were modified as a result of these conversations, and these changes are
described in EPA’s transmittal lette r to the Tribes, dated August 2007.

In spring 2007, while EPA and the Suquamish Tribe were working with the Suquamish Tribe’s data, a discrepancy between the consumption calculations in the data and those used in the Framework was recognized. The Suquamish Tribe reviewed the data and modified its consumption rate. This change is also described in EPA’s
transmittal letter to the Tribes.

Appendix A - 3As explained to the Tribes in December 2004, EPA needed to use the Framework as a pilot, that is, before it would be finali zed, at one or more cleanup sites affecting the Duwamish River. It is currently being used in the Superfund Lower Duwamish Waterway risk assessment. Lessons learned from the pilot application of the Framework have been incorporated into this version.

In summary, this Framework provides a recommended approach for selecting fish and shellfish consumption rates where Tribal consumption of fish and shellfish is evaluated in EPA’s risk assessment proce ss for CERCLA and EPA-lead RCRA sites in Puget Sound and the Strait of Georgia. The approach reflects EPA guidance and policies regarding the exposures due to re leases from contaminated sites. The Framework is designed to provide a consistent approach to developing fish and shellfish consumption
rates and to assist deci sion makers in making risk management decisions.

Application of this Framework in EPA’s RCRA and CERCLA cleanup programs is expected to be performed in consultation with the Tribal govern ments on a site-specific basis. This Framework is not intended to replace government-to-government consultation on specific sites.

EPA’s release of the Framework does not imply concurrence by the Tribes. The Framework is an EPA cleanup program doc ument that has been improved through dialogue with Tribes. Nevertheless, EPA' s release of the Framework should not be construed as any Tribe's concurrence with either the Framework in general or any specific statements or recommendations included in the Framework.

EPA considers the Framework to be a working document that may be revised periodically to incorporate new information and lessons learned.

Nothing in the Framework will limit, modi fy, or change Tribal treaty rights.

Appendix A - 4Appendix B

Fish and Shellfish Mixtures fr om Tribal Consumption Studies

The consumption rate in grams per day for each group of species listed in Appendix B, including salmon, was calculate d using the following steps:

1. The mean consumption rate for adult Tribal members for each group of species was taken from averages reported in Toy et al . (1996) and the Suquamish Tribe (2000).

2. The mean consumption rates were a dded, and this sum was used to estimate the percentage of total fish consumption as cribed to each group of species. This estimate is presented in the co lumn “Percent of Diet.”

3. These percentages were applied to the total ingestion rate selected in Box PS-9 to calculate an estimated consumption rate (g/day) for each group of species.

Step 2, Box PS-10 of this Framework requires the user to select a “reasonable mix of classes of fish and shellfish.” The following tables specify such mixes for the Tulalip and Suquamish Tribes.

Table B-1. Distribution among species groups if the Tulalip Tribes consum ption rate is used in Box

PS-9

Species Grams per day (1) Percent of diet (2)

Salmon 96.4 49.7

Pelagic fish 8.1 4.2

Bottom fish 7.5 3.9

Shellfish 81.9 42.2

Total Ingestion Rate 194 (3) 100

(1) The average body weight for us e with this study is 81.8 kg. (2) Percent of diet is based upon mean data in Table 3, Toy et al ., 1996. (3) The value of 194 g/day in this table is the 95 th percentile total consumption rate for fish and shellfish after adju sting the total consumption rate of 243 g/day to include only fish and shellfish harvested from Puget Sound, Kissinger, 2005.

Appendix B - 1Table B-2. Distribution among species groups if the Suquamish Tribe consumption rate is used in Box PS-9.

Species Grams per day (1) Percent of diet (2) Salmon (Group A) 183.5 23.9 Pelagic Fish (Groups B and C) 56.0 7.3 Bottom Fish (Group D) 29.1 3.8 Shellfish (Groups E and G) 498.4 65 Total Ingestion Rate 766.8 (3) 100

(1) The average body weight for us e with this study is 79 kg. (2) Percent of diet is based upon mean data in Table T-3, The Suquamish Tribe, 2000. Group F is primarily canned and fresh tuna a nd is not included in these calculations. (3) The value of 766.8 g/day in this table is the 95 th percentile total consumption rate for fish and shellfish after adjusting the total consumpti on rate of 796 g/day to include only fish and shellfish harvested from Puget Sound, The Suquamish Tribe, 2007

Appendix B - 2Appendix C

Background Information on the Calculation of Puget Sound Fish and Shellfish Consumption Rates

The 95th percentile, consumer-only Puget Sound fish and shellfish consumption rate for the Tulalip and Suquamish Tribes, as shown in Step 2, Box PS-9 of this Framework, was determined as follows. For each individual, the consumption rate was obtained for each fish and shellfish group ( i.e. , bottom, pelagic, anadromous, and shellfish). The consumption rate for each group was then multiplied by the fract ion of that group obtained by the individual from Puget Sound. The overall consumption rate of fish and shellfish harvested from Puget Sound for each individual was derived by su mming all of the adjusted results.

RateA: Anadromous fish consumption rate, g/kg/day

FPSA: Fraction of anadromous fish harvested from Puget Sound (unitless)

RateP: Pelagic fish consumption rate, g/kg/day

FPSP: Fraction of pelagic fish harv ested from Puget Sound (unitless)

RateB: Bottom fish consumption rate, g/kg/day

FPSB: Fraction of bottom fish harves ted from Puget Sound (unitless)

RateS: Shellfish consumption rate, g/kg/day

FPSS: Fraction of shellfish harves ted from Puget Sound (unitless)

BW: Body weight, kg

Rate (g/day) = [RateA * FPSA + RateP * FPSP + RateB * FPSB + RateS *FPSS] * BW

After a Puget Sound fish and she llfish consumption rate was computed for each individual, rates were ranked from lowest to highest consumption rate. Results for
individuals who did not cons ume any fish harvested from Puget Sound (non-consumers) were discarded from the analysis. From rates for the remaining individuals ( i.e.

, consumers), the rank of the 95th percentile respondent was identified by multiplying the number of consumers by 0.95. Where this co mputation did not resu lt in a whole number rank that identified a specific individual and associated consumption rate, the 95th percentile consumption rate wa s linearly interpolated from the rates of the individuals bracketing the position of the 95th percen tile rank (Kissinger, 2005; The Suquamish Tribe, 2007)

Appendix C - 1Appendix D

Section IV Applied to a Si mple Hypothetical Site

Background

A hypothetical site in Puget Sound is within the U&A of the ABC Tribe. The site has released only one contaminant, X, to groundwater, surface water and sediments. X has cancer and noncancer toxicity values available on the IRIS database. The contaminant is prevalent throughout Puget Sound and the Strait of Georgia waters and is bioaccumulative. The exposure duration for the ABC Tribe is assumed to be the Framework’s default of 70 years, as there is no site-specific inform ation indicating that
Tribal members consume fish and shellfis h from their U&A for fewer than 70 years during their lifetimes.

Site-specific considerations (see Section IV and the Flow Sheet)

Box PS-1: Are Puget Sound fish and she llfish consumption studies relevant? There are no obvious reasons why any of the existing Puget Sound studies are inappropriate for characterization of the A BC Tribe’s seafood consumption. Proceed to

Box PS-2.

Box PS-2: Does the site have extensive shellfish habitat?
The site has limited intertidal habitat. Consequently, proceed to Box PS-5.

Box PS-5: What Tribal study is appropriate for sites with limite d shellfish habitat? For sites with limited intertidal habitat, use Tulalip Tribes data to characterize the consumption rate. Proceed to Box PS-8.

Box PS-8: Proceed to Box PS-9, Se lection of a consumption rate.

Box PS-9: Consult the table in Box PS-9 asso ciating the Tribe and th e consumption rate. The consumption rate associated with the Tu lalip Tribes is 194 g/day. Proceed to Box

PS-10.

Box PS-10: What are appropr iate percentages of the di fferent fish and shellfish categories? It is determined that the percentages for th e Tulalip Tribes as pr ovided in Appendix B, Table B-1 are appropriate. These are as follows, along with consumption rates:

Appendix D - 1Species Grams per day Percent of diet

Salmon 96.4 49.7 Pelagic fish 8.1 4.2

Bottom fish 7.5 3.9

Shellfish 81.9 42.2 Total Ingestion Rate 194 100

Proceed to Box PS-11

Box PS-11: Are salmon affected by local contamination? Adult salmon returning to spawn are known to reside in the general vicinity of the cleanup site for a few days to a week, dur ing which time they are not feeding. The contaminant is known to be readily accumulated by salmon via the food chain. Adult salmon harvested from the vicinity of the site have concentrations of contaminant X that
are similar to those found in salmon harveste d in other areas within Puget Sound and the Strait of Georgia. While the site has re leased contaminant X, the lines of evidence indicate that the preponderan ce of the adult salmon’s body burden of contaminant X was probably acquired in the open ocean or othe r areas of Puget Sound and the Strait of Georgia, remote from the site. The degree to which site-related releases of contaminant X may have been transported to more remote areas of Puget S ound and the Strait of Georgia is unknown. A best professional judgm ent decision is made to not include the contaminant present in locally harvested salmon in the calculation of site-related risk from fish and shellfish consumption. This decision and rationale are discussed with the EPA Region 10 advisory inter-program review group.

Box PS-12: Are there any additional issues to consider in determining whether or not the contaminant might pose site-related risks via c onsumption of other categories of fish or
shellfish?

There are no additional contaminant and aquatic life issues. Bottom and pelagic fish and shellfish tissue of representative speci es will be sampled and the results of the analysis used in the risk assessment. [Note: concentrations in thes e fish could also be estimated through modeling, if appropriate.]

Calculating the intake ra te of the contaminant

The intake rate of the contaminan t via consumption of fish and shellfish tissue may be computed from the following formula. This formula is used to compute the intake rate
of the contaminant based on tissue concentratio ns in each category of fish/shellfish, and is specific to exposures to tissue contaminants that are e xpected to be potentially siterelated. The total site-related intake of c ontaminant X via fish and shellfish consumption is computed by summing the individual rates for each category.

Appendix D - 2Intake of contaminant in mg/kg-day (IR
c ) = (CF i x CR PS x % i x UCF 1 ) /BW [Equation 1]

Where:

IR
c = Intake rate of contaminant X by category of fish/shellfish.

CF i = contaminant concentration (milligrams pe r kilogram, mg/kg) in the tissue of the particular fish or shellfish category, (also referred to as the exposure point concentration).

CR PS = the total consumption rate of fish and shellfish harvested from Puget Sound, 194 grams per day.

% i = the percentage of the i ngestion rate that consists of the category of fish or shellfish, unitless (see table provided for box PS-10, above)

BW = body weight, 81.8 kilograms, observe d from the Tulalip Tribes’study (See Appendix B)

UCF 1 = conversion factor 1, 0.001 kilograms per gram

Intake rates of Contaminant X, by category of fish/shellfish

Overall
Fish/Shellfish Consumption Rate, g/day Category Percent of Consumption

Rate Represented by Category Site-related
concentration of contaminant X, mg/kg, in fish tissue (1) CategorySpecific Exposure, mg/kg-day computed using Equation 1

194 Salmon 49.7 0 ( 2 ) 0

194 Pela g ic Fish 4.2 1.1 0.0001

194 Bottom Fish 3.9 3.1 0.0003

194 Shellfish 42.2 18.6 0.0186

Sum

, I R total

, 0.0190

(1) Concentrations from sampling of bo ttom and pelagic fish and shellfish. (2) Any amount of contaminant X present in sa lmon tissue is assumed in this case to be
from sources remote from and unrelated to the site.

The overall site-related intake rate of contaminant X, IR total , via fish and shellfish consumption is 0.0190 mg/kg-day. This value is now used with appropriate cancer and noncancer toxicity information to calculate the potential risks a nd hazards to Tribal members

Appendix D - 3from consuming this quantity of contaminant X. This is conducted using routine risk algorithms, shown below.

Cancer risk and non-cancer hazard estimates associated with
site-related intake of Contaminant X

Oral cancer slope factor for Contaminant X Oral reference dose for Contaminant X 1.4E-2 (mg/kg-day) -1 2E-2 mg/kg-day

Estimated cancer risk = (IR total x ED x EF x CSF) / (AT x UCF 2 ) [Equation 2]

Where:

IR total = Total intake of contaminant X from s ite-related fish and shellfish consumption, 0.0190 mg/kg-day

ED = exposure duration, 70 years

EF = exposure frequency, 365 days per year

CSF = oral cancer slope factor for contaminant X, 1.4E-2 (mg/kg-day) -1

AT = averaging time, 70 years for carcinogens

UCF 2 = conversion factor 2, (365 days/year)

Estimated cancer risk = [ (.0190 mg/kg-day x 70 yr x 365 d/yr) x (1.4E -2 per mg/kg-day)] / [(70 years) x (365 days/yr)] = 3E-4

Appendix D - 4Estimated hazard index = (IR total x ED x EF x UCF 2 ) / (RfD x AT) [Equation 3]

Where:

IR total = Total intake of contaminant X from site -related fish and shellfish consumption, 0.0190 mg/kg-day

ED = exposure duration, 70 years

EF = exposure frequency, 365 days per year

RfD = Oral reference dose for contaminant X, 2E-2 mg/kg-day

AT = averaging time, the same as expos ure duration for non-carcinogenic effects

UCF 2 = conversion factor 2, (1 yr/365 days)

Estimated hazard index = (0.0190 mg/kg-day x 70 y x 365 d/y x 1 y/365 days) / (2E-2 mg/kg-day x 70 years = 0.95

Summary

The excess individual lifetime cancer risk from Tr ibal consumption of fish and shellfish that may be affected by site-related releases of contaminant X is estimated to be 3E-4.

The hazard quotient from Tribal consumption of fish and shellfish that may be affected by
site-related releases of contamin ant X is estimated to be 0.95.

These estimates, and their associated exposure and toxicity uncertainties, will be presented
and evaluated in the risk char acterization document to be used in making risk management
decisions for the site.

Appendix D - 5