Summary Comments
on PCB Assessment
by Wisconsin
Division of Health

Detailed Comments on
WDOH Assessment

Clean-up Plan
Report Summary

Report Contents

Clean-up Plan
Risk Assessment
Review and Analysis

Feasibility Study
Review and Analysis

Proposed Cleanup
(Action) Levels for
the Fox River and
Green Bay

Literature Cited

Complete Report
for easy printing

About Dr. Foran

Dr. Foran's CV (PDF)

Technical Assistance
Grant (TAG)

Back to Toxicologist Critical of State’s PCB Health Risk Assessment
 

1.0 Introduction The Wisconsin Department of Health and Family Services (DHFS), Division of Public Health, has prepared a Public Health Assessment for PCB-contaminated sediment in the lower Fox River and Green Bay.  The purpose of the assessment is to “describe the existing health issues related to PCB-contaminated sediments…and to recommend actions to reduce risks to human health.”

Below, we provide comments on the DHFS Public Health Assessment.  These comments address three areas:  1) Assessment of health risks of exposure to PCBs and other contaminants; 2) DHFS endorsement of the WDNR/U.S. EPA Proposed Remedial Action Plan for the Fox River and Green Bay; 3) DHFS fish consumption advisories for the Fox River/Green Bay region.

2.0 Assessment of Health Risks

DHFS begins its assessment by providing a description of the project area, including a description of the health effects of exposure to polychlorinated biphenyls (PCBs).  As a public health assessment, the description of PCB health effects is insufficient.  Six short paragraphs are devoted to this description.  In contrast, the ATSDR has prepared a 700+ page toxicological profile for PCBs.  While DHFS should not reproduce the ATSDR Toxicological Profile (to which it refers in the assessment), it should at least provide a comprehensive review of the health effects of exposure to PCBs.  This is critical as the health effects of exposure to PCBs form the basis of recommendations for actions to cleanup and remove PCBs from the lower Fox River and Green Bay. 

The DHFS assessment is also insufficient in that it does not evaluate the quality, nor does it make recommendations for improvement of the Baseline Human Health Risk Assessment (BLHHRA), which was prepared for the WDNR to support the proposed remedial action plan for the Fox River and Green Bay.  Therefore, DHFS should revise its health assessment and include at least the following issues in a comprehensive review of PCB’s health effects.

2.1 Cumulative Assessment of Health Risks

A comprehensive public health assessment should include an assessment of cumulative PCB exposures, and concurrently note the lack of such an assessment in the BLHHRA.  ATSDR states in its PCB Toxicological Profile that, while the manufacture of PCBs has been banned, significant human exposure continues to occur from both the environment and the work place.  ATSDR states further that, while food consumption has been and continues to be one of the major sources of body burden of PCBs in the general population,  human exposure to PCBs has also been attributed to inhalation of indoor air, especially at locations that still use [products] containing PCBs.

While the most significant exposure route in the Fox River basin may be through consumption of contaminated fish, other exposure routes, such as consumption of contaminated waterfowl, and sediment exposure through wading and marine construction are also acknowledged in the BLHHRA.  However, DHFS dismisses non-fish exposure routes as insignificant, as does the BLHHRA.  While these routes may pose relatively low risks individually, they each contribute to the total PCB burden in humans and to adverse health risks associated with that total burden.  As such, the DHFS should call for an assessment of non-fish PCB exposure routes as part of a cumulative risk assessment of PCBs in the BLHHRA. 

Similarly, the DHFS assessment fails to include information on health risks associated with concurrent exposure to PCBs and a variety of other contaminants in Fox River/Green Bay sediments.  Most important among these contaminants, which are discussed in the BLHHRA, are the chlorinated dioxins, DDT, dieldrin, and mercury.  Some of these contaminants share mechanism and effect similarities with many PCB congeners, and some interact with PCB toxicity in an additive or synergistic fashion.  While the RI/FS argues correctly that cleanup of PCB-contaminated sediment will remove some of these contaminants, an assessment of cumulative health risks in the DHFS assessment would provide a much more powerful and compelling argument for a stringent and comprehensive cleanup.  Emphasizing the interactive nature of many environmental contaminants would also serve as an important educational and motivational tool by providing additional incentive and precedent to consider these issues and to drive cleanups at other contaminated sites.

Finally, the DHFS should discuss the importance of a comprehensive assessment that addresses the cumulative risks of concurrent exposure to multiple contaminants from multiple sources.  Cumulative risk assessment is currently being used by the U.S. EPA, as mandated by the Food Quality Protection Act of 1996.  Methodology has been developed for cumulative risk assessment, and should be used as part of a comprehensive public health assessment for contaminant exposure in the Fox River/Green Bay region.

2.2 Presentation of Risk Information

The health risk estimates for both cancer and non-cancer effects in the BLHHRA provide a compelling reason to clean up contaminated sediments in the Fox River and Green Bay.  Cancer risk estimates as high as 1X10-3, and hazard indices greater than 100 cannot be ignored, and should drive immediate and aggressive action.  Yet, the DHFS public health assessment makes no mention of this information.  DHFS should revise its public health assessment by citing the risk estimates provided in the PRAP and supporting documents, and by using these estimates to call for a thorough and stringent cleanup of the Fox River and Green Bay.  On the other hand, if DHFS believes that the risk estimates in the BLHHRA are flawed, recommendations for their improvement should be provided by DHFS.  To this end, DHFS should carefully consider the comments of Dr. Jeffery Foran on the RI/FS/RA and PRAP.  In these comments, Dr. Foran argues that estimates, while highly elevated, may actually underestimate risk as a result of the use of non-conservative assumptions regarding fish preparation and fish consumption behaviors in the BLHHRA. 

The DHFS must also revise its discussion of the potential carcinogenicity of PCBs as it is presented in the draft public health assessment.  The DHFS assessment should state, consistent with the U.S. EPA, the U.S. NTP, and IARC, that PCBs are classified as probable human carcinogens, rather than “probably carcinogenic to humans.”  The former, formal classification is both standardized and internationally accepted while the statement in the DHFS public health assessment trivializes the human carcinogenicity of PCBs. 

The DHFS health assessment is flawed in its conclusion (page 10) that exposure frequency, duration of exposure, and dose of PCBs from swimming, wading, and marine construction pose no increased health risk.  The ATSDR, U.S. EPA, IARC, NTP, and other scientific and regulatory agencies have concluded that PCBs are probable human carcinogens, and that the carcinogenic mechanism indicates that there are adverse health risks associated with any level of exposure, no matter how low.

The mechanisms by which PCBs cause cancer have been the focus of a great deal of research. ATSDR has concluded that "although the available data indicate that PCBs are not potent genotoxicants, there is some experimental support for the possible involvement of genotoxic mechanisms in the development of PCB-induced cancer."   Therefore, approaches to the assessment of cancer risk for PCBs should not incorporate a mechanistic threshold.  Rather, the method used by the WDNR consultant, and endorsed by the EPA, ATSDR, and others, suggests that there is an elevated risk of cancer even at the lowest exposures.  Zero risk of cancer occurs only where there is no (zero) exposure.  Therefore, the statement on page 10 of no increased health risk is in error, where even small exposures occur from activities such as wading and swimming.  While the incremental increase in health risk may be low, it is not zero, and therefore should be considered, particularly as part of a cumulative risk assessment for PCBs and other contaminants.

3.0  Endorsement of the U.S. EPA/WDNR Proposed Remedial Action Plan

The DHFS public health assessment endorses the proposed remedial action plan (PRAP) prepared by the WDNR and the U.S. EPA.  At the same time, the DHFS assessment recommends that cleanup actions be taken to “reduce the amount of PCBs available for uptake into the food chain,” and that “cleanup remedies be selected based on their ability to most effectively reduce reliance on fish consumption advisories.”  DHFS’s support of the PRAP and their admonition to reduce PCBs in the food chain by selecting the most effective cleanup remedies are in direct conflict with each other.

3.1  Proposal to clean up the Fox River

The draft feasibility study indicates that a PCB sediment quality threshold (SQT) between 1 and 10 ug/kg (ppb) is required to fully protect human health (by reducing PCB in fish tissue).  Yet, the WDNR and the U.S. EPA have selected a 1ppm PCB cleanup level for portions of the Fox River, which is 100 to 1000 times less protective than the cleanup level required to reduce contaminants in fish tissue, eliminate fish consumption advisories, and protect public health.  The inadequacy of a 1ppm cleanup level is documented in the WDNR/EPA Feasibility Study, which concludes this cleanup level will require a waiting period for elimination of consumption advisories of at least 30 years in OU 1, over 40 years in OU 3, and 60 years in OU 4.  Therefore, a cleanup level of 1ppm will not achieve the DHFS goal in a timely fashion, and DHFS should call for a more stringent cleanup level, at or below 0.25 mg/kg (ppm), which will result in significantly lower sediment PCB concentrations and elimination of the need for consumption advisories in a much shorter period of time. 

The Wisconsin DNR and the U.S. EPA have recommended that no PCB cleanup occur in Fox River OU 2 (Appleton to Little Rapids).  Rather, the proposed alternative for this reach is Monitored Natural Recovery  (MNR).  DNR and EPA state that use of this no action alternative in OU2 will require 70 years or more to reduce PCB sediment concentrations to levels that will result in elimination of fish consumption advisories.  However, MNR is based on the faulty assumption that PCBs will degrade naturally in the Fox River and, as such, do not require removal to protect human health.  The EPA/DNR draft Feasibility Study, as well as the vast scientific literature on PCBs conclude that natural degradation of PCBs in sediments does not and will not occur in the Fox River or Green Bay.  Therefore, the no cleanup alternative for OU 2 may never achieve PCB sediment concentrations that are protective of human health. 

The DHFS must recognize that the proposed remedial action plan for the Fox River is inadequate and will not achieve DHFS’s goal of “effectively reducing reliance on fish consumption advisories” in the Fox River.  Therefore, DHFS must revise its health assessment to call on WDNR and U.S. EPA to strengthen the cleanup plan by adopting a sediment action level (cleanup level) of 0.25 mg/kg (ppm) for all river reaches.

3.2  Proposal to avoid cleanup of Green Bay

The Wisconsin DNR and the U.S. EPA have proposed no cleanup for Green Bay, including the highly contaminated inner bay, referred to as Zone 2.  The WDNR and EPA support the no cleanup alternative by suggesting that the PCB mass in the bay is distributed over a very large area, is contained in a very large volume of sediment, and that the costs of Zone 2 cleanup are very high.  However, the WDNR and EPA admit that, with the no cleanup alternative, PCB concentrations in Green Bay sediments will remain high enough to require fish consumption advisories for at least 100-years into the future (the end of the time frame evaluated in the feasibility study). 

DHFS must call on the WDNR and the U.S. EPA to develop and implement a strong cleanup plan for Green Bay, including adoption a cleanup action level of 0.25 mg/kg, consistent with cleanup levels in the Fox River.  A strong cleanup plan will benefit human health by reducing cancer and non-cancer health risks in residents of the region, and achieve the DHFS goal of reducing or eliminating the need for fish consumption advisories in the Bay.
4.0 Failure of Fish Consumption Advisories to Protect Human Health
Fish consumption advisories (FCA) are an unfortunate but necessary means to protect public health from the effects of contaminants in fish tissues.  Remedial and proactive approaches to pollution reduction and prevention must be pursued aggressively to reduce and ultimately eliminate the need for fish consumption advisories in the Fox River and Green Bay, throughout Wisconsin, and throughout the Great Lakes region.  However, since pollutant reduction and prevention efforts will not eliminate the need for fish consumption advisories immediately, advisories themselves must be developed and implemented in ways that will fully protect public and human health.  Unfortunately, DHFS’s own assessment of its consumption advisory program indicates that FCAs are not achieving this goal.

DHFS acknowledges in its public health assessment that, on average, only half (50%) of Wisconsin residents who consume sport-caught fish are aware of advisories to reduce or eliminate consumption of highly contaminated species.  FCA efficacy is worse for women (40 % are aware of FCAs), and far worse for minorities (only 22% are aware of FCAs).  In the Fox River/Green Bay region, a 1997 survey reports that 50% of surveyed anglers consume contaminated fish from the Fox River, and between 70% and 80% of minorities (including Hmong, Loatian, African-American, and Hispanic anglers) reported eating fish from the river, even though many of these individuals report some knowledge of contamination problems in the River and Bay.

There appears to be several reasons for the poor efficacy of fish consumption advisories.  DHFS reports that only 40,000 advisories are printed and distributed in Wisconsin each year, enough for only 3.2% of the 1.25 million licensed anglers in the state.  Even if all advisory brochures were distributed in the counties bordering the Fox River (which is clearly not the case since advisories are distributed throughout the state), there would still be an inadequate supply for all 47,000 licensed anglers in those counties, and far too few for all licensed anglers in counties bordering the Fox River and Green Bay. 

Further, not all individuals, and many minority and subsistence anglers do not purchase fishing licenses; thus, there is no possibility that these individuals would receive consumption advisory brochures.  Finally, even where consumption advice reaches minorities and low-income individuals, studies indicate that these individuals continue to consume their catch for economic, nutritional, and cultural reasons; thus, the efficacy of consumption advisories in these cases is reduced even further.

DHFS has indicated that it has taken steps in the Fox River region to improve the dissemination of consumption advice for contaminated fish, including contact with minority communities through distribution of a video, local workshops, posting of signs, and other means.  Unfortunately, there is no discussion, and apparently there are no data to indicate whether these steps have improved awareness of consumption advisories and, more important, resulted in reduced consumption of contaminated species and exposure to contaminants.  In fact, in a 1998 survey, DHFS reported “some anglers complained that they were not notified sooner about PCB-contaminated fish in the Lower Fox River and are worried that their families are [being harmed].”  This indicates that DHFS actions to improve dissemination of consumption advice have been unsuccessful.  Further, DHFS shows a callous disregard for the cultural traditions of local residents by suggesting that the only solution is for these individuals to break with their cultural traditions to reduce contaminant exposure.

Finally, the public health assessment suggests that DHFS fish consumption advisories, which indicate how much and which fish are safe to eat, are “based on the work of public health, water quality, and fisheries experts from the eight Great Lakes states and Ontario.”  The U.S. EPA has published a protocol to guide states in their development of fish consumption advisories (www.epa.gov/ost/fishadvice/volume2/), which is risk-based and designed to be fully protective of human and public health.  Unfortunately, Wisconsin and the other Great Lakes states have chosen not to follow the U.S. EPA protocol for FCA development.  As a result, fish consumption advice in the Great Lakes states, and specifically in the Fox River and Green Bay region, is less stringent and less health protective than advice developed using EPA protocols.  For example, the Wisconsin fish consumption advisory for the Fox River indicates that perch, some size classes of walleye, and several other species can be eaten as frequently as once per month to once per week.  Similarly, the advisory indicates that some size classes of walleye and rainbow trout from Green Bay can be eaten as frequently as once per month.  However, if EPA methodology were used to generate consumption advice for these species, FCAs would warn to virtually eliminate all consumption of these species and size classes.

5.0 Recommendations

The Wisconsin Department of Health and Family Services has an important opportunity to reduce the public health threats of exposure to contaminants in the Fox River and Green Bay.   The DHFS Public Health Assessment for the region should be used to achieve this goal, in part by calling for a strong cleanup plan that removes contaminated sediments from both the Fox River and Green Bay to levels that will fully protect human health.  As it is currently written, however, the public health assessment is inadequate and will not result in reduction of public health threats in the region.  Therefore, the public health assessment should be improved and strengthened as follows:

The assessment should provide a comprehensive review of the health effects of exposure to PCBs as well as other contaminants in the sediments of the Fox River and Green Bay.  It should also present a review of the health risk estimates for exposure to these contaminants presented in the BLHHRA.  This information should then be used to develop and support recommendations for strong actions to clean up and remove PCBs and other contaminants in sediments of the lower Fox River and Green Bay.

The DHFS assessment should state explicitly that the proposed remedial action plan for the Fox River and Green Bay is inadequate and will not achieve the DHFS goal of eliminating the need for fish consumption advisories in the region.  The DHFS assessment should then call on WDNR and U.S. EPA to strengthen the proposed cleanup plan by adopting a sediment action level (cleanup level) of 0.25 mg/kg (ppm) for the entire Fox River and for Green Bay.  A strong cleanup plan will benefit human health by reducing cancer and non-cancer health risks in residents of the region, and concurrently achieve the DHFS goal of reducing or eliminating the need for fish consumption advisories.

Since pollutant reduction and prevention efforts in the Fox River and Green Bay will not immediately eliminate the need for fish consumption advisories, DHFS should develop and implement advisories in ways that will fully protect public and human health.  To this end, the DHFS should:

• Immediately adopt U.S. EPA methods for consumption advisory development, and begin work with the other Great Lakes states to revise and strengthen regional fish consumption advisories;

• Develop new approaches for the dissemination of consumption advisories in the Fox River/Green Bay region, with a goal of significant improvement in the efficacy of advisories in changing consumption behavior and in reducing contaminant exposure; 

• Develop and implement assessment methods to track the efficacy of FCA programs in the Fox River/Green Bay region, and use information from these programs to modify and improve the efficacy of communication methods.