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Health Consultation
Review of Lead Levels in Clam Tissue
CALLAHAN MINE SUPERFUND SITE BROOKSVILLE HANCOCK COUNTY MAINE
EPA FACILITY ID MED980524128
October 24 2008
US DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service Agency for Toxic Substances and Disease Registry Division of Health Assessment and Consultation
Atlanta Georgia 30333
Health Consultation A Note of Explanation
An ATSDR health consultation is a verbal or written response from ATSDR to a specific request for information about health risks related to a specific site a chemical release or the presence of hazardous material In order to prevent or mitigate exposures a consultation may lead to specific actions such as restricting use of or replacing water supplies intensifying environmental sampling restricting site access or removing the contaminated material
In addition consultations may recommend additional public health actions such as conducting health surveillance activities to evaluate exposure or trends in adverse health outcomes conducting biological indicators of exposure studies to assess exposure and providing health education for health care providers and community members This concludes the health consultation process for this site unless additional information is obtained by ATSDR which in the Agencyrsquos opinion indicates a need to revise or append the conclusions previously issued
You May Contact ATSDR Toll Free at 1-800-CDC-INFO
or Visit our Home Page at httpwwwatsdrcdcgov
HEALTH CONSULTATION
Review of Lead Levels in Clams Tissue
CALLAHAN MINE SUPERFUND SITE BROOKSVILLE HANCOCK COUNTY MAINE
EPA FACILITY ID MED980524128
Prepared by
US Department of Health and Human Services Agency for Toxic Substances and Disease Registry
Callahan Mine Site Health Consultation
Statement of Issues On October 2 2008 the US Environmental Protection Agency (EPA) requested the Agency for Toxic Substances and Disease Registry (ATSDR) provide comments about the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model in a clam evaluation technical memorandum In light of new sampling data EPA has also requested ATSDR review the new data and advise on the relevance of the existing fish and shellfish consumption restrictions specifically whether those advisories should continue as currently issued This EPA request is being managed by ATSDR under the ldquoStrikerdquo process which is a rapid-response focused effort that does not include comprehensive review of the technical memorandum site contaminants and exposure pathways
Background The Callahan Mine site is located east-southeast of Harborside Village in the Town of Brooksville Hancock County Maine The site is the former location of a zinccopper open-pit mine The Callahan Mining Corporation operated the zinccopper mine at the site during 1881ndash 1887 and 1968ndash1972 The mine operated adjacent to and beneath Goose Pond a tidal estuary The property comprises 150 acres and is located in a coastal rural setting on the Cape Rosier peninsula The property abuts Goose Pond to the east and private properties to the west south and north The site consists of large waste piles (waste rock piles) a tailings pond and mine operations buildings and structures The open-pit mine flooded from a dam opening at Goose Falls in 1972 The mine is currently under water and is subject to daily tidal exchange in Goose Pond An interconnection exists between Goose Pond and Goose Cove to the north by a reversing falls known as Goose Falls Goose Cove is located on the southern part of Penobscot Bay
In September 2002 EPA added the site to the National Priorities List (NPL) Environmental sampling included soil sediment surface water groundwater seeps and biota from the site and surrounding areas A Draft Human Health Risk Assessment (HHRA) was completed and published in March 2008
In June 2008 ATSDR reviewed limited data provided by EPA to determine if people should not eat clams because of the lead levels in clams ATSDR concluded that levels of lead in sampled clams exceed the US Food and Drug Administration (FDA) safety tolerance level and the maximum value of lead found in the Total Diet Study ATSDR recommended that individuals continue to adhere to the existing fish and shellfish consumption restrictions and advisories in the area [ATSDR 2008]
Discussion ATSDR provides site-specific public health recommendations based on available toxicological literature levels of environmental contaminants detected at a site compared to accepted comparison values an evaluation of potential exposure pathways and the characteristics of the exposed population
According to the technical memorandum it is highly improbable that commercial clam harvesting would occur at Goose Pond because clams are not easily harvestable from the pond [MACTEC 2008b] The memorandum also concludes it is unlikely that recreational clam harvesting would occur in Goose Pond at least by local landowners who are familiar with the
1
Callahan Mine Site Health Consultation
area The memorandum states however that recreational clam harvesting by vacationers or new residents to the area might occur and that it is likely the frequency at which a single person would obtain clams from Goose Pond would be limited to only one or two meals per year and would not exceed five meals per year [MACTEC 2008b]
For this STRIKE request ATSDR reviewed the technical memorandum regarding the clam evaluation to provide comments about the use of the IEUBK lead model ATSDR also reviewed the recent sampling data to determine if people should not eat clams because of the lead levels in clams
ATSDRrsquos comments on the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model
In the technical memorandum preliminary remediation goals (PRGs) for lead in sediment that are protective for consumption of lead in clam tissue were calculated [MACTEC 2008b] PRGs were derived for the clam consumption scenarios that posed lead risks in excess of EPA risk management criteria using the IEUBK model
EPArsquos IEUBK model is the most common application used to estimate potential risk from exposure to lead The model is designed to integrate chronic and relatively stable exposures from lead in air water soil dust diet paint and other sources with pharmacokinetic modeling to predict blood lead concentrations in children 6 months to 7 years of age [EPA 1994] One limitation of the model is that it was not designed to assess short-term periodic or acute exposures The reliability of the model for predicting blood level concentrations for exposure durations shorter than 3 months has not been assessed If those intermittent exposures are time-averaged over the entire year the model may underestimate blood lead levels in children [EPA 2003 Lorenzana et al 2005] Because the focus of the model is children under age 7 model results will tend to over predict blood lead concentrations for older children and adults
The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
Clam tissue lead contamination evaluation
A potential human exposure pathway for this site is consuming contaminated biota such as clams harvested in the area Shell fish beds at and in the vicinity of the site are closed by the State and a shellfish ban is currently in effect for Goose Pond Goose Cove and other nearby areas The ban states that no shellfish (including clams mussels and oysters) should be collected or consumed from designated areas [MACTEC 2008a] Although under current conditions consumption of shellfish is not a completed pathway future land use of the area may change the situation
ATSDR used the US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) safety tolerance level for lead and the FDA total diet study results for element levels in market basket surveys for comparison The lead safety tolerance level of 17 milligrams per kilogram (mgkg) represents a point at or above which the FDA will take action
2
Callahan Mine Site Health Consultation
to remove products from the market [FDA 2001] The total diets study indicated that the maximum lead concentration found in the food we consume is 0026 mgkg [FDA 2006]
MACTEC Engineering and Consulting Inc personnel collected 24 pairs of clam and sediment samples from Goose Pond during the weeks of July 28 and August 4 2008 Each cooked clam tissue sample was analyzed twice once on August 14 2008 and once on August 15 2008 The average lead concentrations of the two runs (067- 28 mgkg) in cooked clam tissue samples were used in the IEBUK model The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008 and exceed the FDA safety tolerance level and the maximum value of lead found in the total diet study Therefore ATSDRrsquos conclusions and recommendations from the June 2008 health consultation remain the same specifically ATSDR finds that residents and visitors to the area should continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist
Child Health Considerations Children could be at greater risk than adults are after certain kinds of exposure to hazardous substances A childrsquos lower body weight results in a greater dose of hazardous substance per unit of body weight Children also are more active and have higher heart and respiratory rates causing them to have higher peak and mean exposures If toxic exposure levels are high enough during critical growth stages the developing body systems of children can sustain permanent damage Based on Callahan Mine site sampling data ATSDR considers that exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
Conclusions ATSDR reviewed the technical memorandum sections related to the use of the IEUBK model for lead risk evaluation ATSDR also reviewed the recent sampling data to determine whether people should not eat clams because of the lead levels in clams Based on the available information ATSDR reached the following conclusions
bull Exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
bull The levels of lead in cooked clam tissue samples exceeded the FDA safety tolerance level and the maximum value of lead found in the total diet study
bull The average levels of lead in cooked clam tissue samples from the site ranged from 067shy28 mgkg The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008
bull The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
3
Callahan Mine Site Health Consultation
Recommendations ATSDR recommends that individuals continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist in the area
4
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Health Consultation A Note of Explanation
An ATSDR health consultation is a verbal or written response from ATSDR to a specific request for information about health risks related to a specific site a chemical release or the presence of hazardous material In order to prevent or mitigate exposures a consultation may lead to specific actions such as restricting use of or replacing water supplies intensifying environmental sampling restricting site access or removing the contaminated material
In addition consultations may recommend additional public health actions such as conducting health surveillance activities to evaluate exposure or trends in adverse health outcomes conducting biological indicators of exposure studies to assess exposure and providing health education for health care providers and community members This concludes the health consultation process for this site unless additional information is obtained by ATSDR which in the Agencyrsquos opinion indicates a need to revise or append the conclusions previously issued
You May Contact ATSDR Toll Free at 1-800-CDC-INFO
or Visit our Home Page at httpwwwatsdrcdcgov
HEALTH CONSULTATION
Review of Lead Levels in Clams Tissue
CALLAHAN MINE SUPERFUND SITE BROOKSVILLE HANCOCK COUNTY MAINE
EPA FACILITY ID MED980524128
Prepared by
US Department of Health and Human Services Agency for Toxic Substances and Disease Registry
Callahan Mine Site Health Consultation
Statement of Issues On October 2 2008 the US Environmental Protection Agency (EPA) requested the Agency for Toxic Substances and Disease Registry (ATSDR) provide comments about the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model in a clam evaluation technical memorandum In light of new sampling data EPA has also requested ATSDR review the new data and advise on the relevance of the existing fish and shellfish consumption restrictions specifically whether those advisories should continue as currently issued This EPA request is being managed by ATSDR under the ldquoStrikerdquo process which is a rapid-response focused effort that does not include comprehensive review of the technical memorandum site contaminants and exposure pathways
Background The Callahan Mine site is located east-southeast of Harborside Village in the Town of Brooksville Hancock County Maine The site is the former location of a zinccopper open-pit mine The Callahan Mining Corporation operated the zinccopper mine at the site during 1881ndash 1887 and 1968ndash1972 The mine operated adjacent to and beneath Goose Pond a tidal estuary The property comprises 150 acres and is located in a coastal rural setting on the Cape Rosier peninsula The property abuts Goose Pond to the east and private properties to the west south and north The site consists of large waste piles (waste rock piles) a tailings pond and mine operations buildings and structures The open-pit mine flooded from a dam opening at Goose Falls in 1972 The mine is currently under water and is subject to daily tidal exchange in Goose Pond An interconnection exists between Goose Pond and Goose Cove to the north by a reversing falls known as Goose Falls Goose Cove is located on the southern part of Penobscot Bay
In September 2002 EPA added the site to the National Priorities List (NPL) Environmental sampling included soil sediment surface water groundwater seeps and biota from the site and surrounding areas A Draft Human Health Risk Assessment (HHRA) was completed and published in March 2008
In June 2008 ATSDR reviewed limited data provided by EPA to determine if people should not eat clams because of the lead levels in clams ATSDR concluded that levels of lead in sampled clams exceed the US Food and Drug Administration (FDA) safety tolerance level and the maximum value of lead found in the Total Diet Study ATSDR recommended that individuals continue to adhere to the existing fish and shellfish consumption restrictions and advisories in the area [ATSDR 2008]
Discussion ATSDR provides site-specific public health recommendations based on available toxicological literature levels of environmental contaminants detected at a site compared to accepted comparison values an evaluation of potential exposure pathways and the characteristics of the exposed population
According to the technical memorandum it is highly improbable that commercial clam harvesting would occur at Goose Pond because clams are not easily harvestable from the pond [MACTEC 2008b] The memorandum also concludes it is unlikely that recreational clam harvesting would occur in Goose Pond at least by local landowners who are familiar with the
1
Callahan Mine Site Health Consultation
area The memorandum states however that recreational clam harvesting by vacationers or new residents to the area might occur and that it is likely the frequency at which a single person would obtain clams from Goose Pond would be limited to only one or two meals per year and would not exceed five meals per year [MACTEC 2008b]
For this STRIKE request ATSDR reviewed the technical memorandum regarding the clam evaluation to provide comments about the use of the IEUBK lead model ATSDR also reviewed the recent sampling data to determine if people should not eat clams because of the lead levels in clams
ATSDRrsquos comments on the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model
In the technical memorandum preliminary remediation goals (PRGs) for lead in sediment that are protective for consumption of lead in clam tissue were calculated [MACTEC 2008b] PRGs were derived for the clam consumption scenarios that posed lead risks in excess of EPA risk management criteria using the IEUBK model
EPArsquos IEUBK model is the most common application used to estimate potential risk from exposure to lead The model is designed to integrate chronic and relatively stable exposures from lead in air water soil dust diet paint and other sources with pharmacokinetic modeling to predict blood lead concentrations in children 6 months to 7 years of age [EPA 1994] One limitation of the model is that it was not designed to assess short-term periodic or acute exposures The reliability of the model for predicting blood level concentrations for exposure durations shorter than 3 months has not been assessed If those intermittent exposures are time-averaged over the entire year the model may underestimate blood lead levels in children [EPA 2003 Lorenzana et al 2005] Because the focus of the model is children under age 7 model results will tend to over predict blood lead concentrations for older children and adults
The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
Clam tissue lead contamination evaluation
A potential human exposure pathway for this site is consuming contaminated biota such as clams harvested in the area Shell fish beds at and in the vicinity of the site are closed by the State and a shellfish ban is currently in effect for Goose Pond Goose Cove and other nearby areas The ban states that no shellfish (including clams mussels and oysters) should be collected or consumed from designated areas [MACTEC 2008a] Although under current conditions consumption of shellfish is not a completed pathway future land use of the area may change the situation
ATSDR used the US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) safety tolerance level for lead and the FDA total diet study results for element levels in market basket surveys for comparison The lead safety tolerance level of 17 milligrams per kilogram (mgkg) represents a point at or above which the FDA will take action
2
Callahan Mine Site Health Consultation
to remove products from the market [FDA 2001] The total diets study indicated that the maximum lead concentration found in the food we consume is 0026 mgkg [FDA 2006]
MACTEC Engineering and Consulting Inc personnel collected 24 pairs of clam and sediment samples from Goose Pond during the weeks of July 28 and August 4 2008 Each cooked clam tissue sample was analyzed twice once on August 14 2008 and once on August 15 2008 The average lead concentrations of the two runs (067- 28 mgkg) in cooked clam tissue samples were used in the IEBUK model The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008 and exceed the FDA safety tolerance level and the maximum value of lead found in the total diet study Therefore ATSDRrsquos conclusions and recommendations from the June 2008 health consultation remain the same specifically ATSDR finds that residents and visitors to the area should continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist
Child Health Considerations Children could be at greater risk than adults are after certain kinds of exposure to hazardous substances A childrsquos lower body weight results in a greater dose of hazardous substance per unit of body weight Children also are more active and have higher heart and respiratory rates causing them to have higher peak and mean exposures If toxic exposure levels are high enough during critical growth stages the developing body systems of children can sustain permanent damage Based on Callahan Mine site sampling data ATSDR considers that exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
Conclusions ATSDR reviewed the technical memorandum sections related to the use of the IEUBK model for lead risk evaluation ATSDR also reviewed the recent sampling data to determine whether people should not eat clams because of the lead levels in clams Based on the available information ATSDR reached the following conclusions
bull Exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
bull The levels of lead in cooked clam tissue samples exceeded the FDA safety tolerance level and the maximum value of lead found in the total diet study
bull The average levels of lead in cooked clam tissue samples from the site ranged from 067shy28 mgkg The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008
bull The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
3
Callahan Mine Site Health Consultation
Recommendations ATSDR recommends that individuals continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist in the area
4
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
HEALTH CONSULTATION
Review of Lead Levels in Clams Tissue
CALLAHAN MINE SUPERFUND SITE BROOKSVILLE HANCOCK COUNTY MAINE
EPA FACILITY ID MED980524128
Prepared by
US Department of Health and Human Services Agency for Toxic Substances and Disease Registry
Callahan Mine Site Health Consultation
Statement of Issues On October 2 2008 the US Environmental Protection Agency (EPA) requested the Agency for Toxic Substances and Disease Registry (ATSDR) provide comments about the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model in a clam evaluation technical memorandum In light of new sampling data EPA has also requested ATSDR review the new data and advise on the relevance of the existing fish and shellfish consumption restrictions specifically whether those advisories should continue as currently issued This EPA request is being managed by ATSDR under the ldquoStrikerdquo process which is a rapid-response focused effort that does not include comprehensive review of the technical memorandum site contaminants and exposure pathways
Background The Callahan Mine site is located east-southeast of Harborside Village in the Town of Brooksville Hancock County Maine The site is the former location of a zinccopper open-pit mine The Callahan Mining Corporation operated the zinccopper mine at the site during 1881ndash 1887 and 1968ndash1972 The mine operated adjacent to and beneath Goose Pond a tidal estuary The property comprises 150 acres and is located in a coastal rural setting on the Cape Rosier peninsula The property abuts Goose Pond to the east and private properties to the west south and north The site consists of large waste piles (waste rock piles) a tailings pond and mine operations buildings and structures The open-pit mine flooded from a dam opening at Goose Falls in 1972 The mine is currently under water and is subject to daily tidal exchange in Goose Pond An interconnection exists between Goose Pond and Goose Cove to the north by a reversing falls known as Goose Falls Goose Cove is located on the southern part of Penobscot Bay
In September 2002 EPA added the site to the National Priorities List (NPL) Environmental sampling included soil sediment surface water groundwater seeps and biota from the site and surrounding areas A Draft Human Health Risk Assessment (HHRA) was completed and published in March 2008
In June 2008 ATSDR reviewed limited data provided by EPA to determine if people should not eat clams because of the lead levels in clams ATSDR concluded that levels of lead in sampled clams exceed the US Food and Drug Administration (FDA) safety tolerance level and the maximum value of lead found in the Total Diet Study ATSDR recommended that individuals continue to adhere to the existing fish and shellfish consumption restrictions and advisories in the area [ATSDR 2008]
Discussion ATSDR provides site-specific public health recommendations based on available toxicological literature levels of environmental contaminants detected at a site compared to accepted comparison values an evaluation of potential exposure pathways and the characteristics of the exposed population
According to the technical memorandum it is highly improbable that commercial clam harvesting would occur at Goose Pond because clams are not easily harvestable from the pond [MACTEC 2008b] The memorandum also concludes it is unlikely that recreational clam harvesting would occur in Goose Pond at least by local landowners who are familiar with the
1
Callahan Mine Site Health Consultation
area The memorandum states however that recreational clam harvesting by vacationers or new residents to the area might occur and that it is likely the frequency at which a single person would obtain clams from Goose Pond would be limited to only one or two meals per year and would not exceed five meals per year [MACTEC 2008b]
For this STRIKE request ATSDR reviewed the technical memorandum regarding the clam evaluation to provide comments about the use of the IEUBK lead model ATSDR also reviewed the recent sampling data to determine if people should not eat clams because of the lead levels in clams
ATSDRrsquos comments on the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model
In the technical memorandum preliminary remediation goals (PRGs) for lead in sediment that are protective for consumption of lead in clam tissue were calculated [MACTEC 2008b] PRGs were derived for the clam consumption scenarios that posed lead risks in excess of EPA risk management criteria using the IEUBK model
EPArsquos IEUBK model is the most common application used to estimate potential risk from exposure to lead The model is designed to integrate chronic and relatively stable exposures from lead in air water soil dust diet paint and other sources with pharmacokinetic modeling to predict blood lead concentrations in children 6 months to 7 years of age [EPA 1994] One limitation of the model is that it was not designed to assess short-term periodic or acute exposures The reliability of the model for predicting blood level concentrations for exposure durations shorter than 3 months has not been assessed If those intermittent exposures are time-averaged over the entire year the model may underestimate blood lead levels in children [EPA 2003 Lorenzana et al 2005] Because the focus of the model is children under age 7 model results will tend to over predict blood lead concentrations for older children and adults
The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
Clam tissue lead contamination evaluation
A potential human exposure pathway for this site is consuming contaminated biota such as clams harvested in the area Shell fish beds at and in the vicinity of the site are closed by the State and a shellfish ban is currently in effect for Goose Pond Goose Cove and other nearby areas The ban states that no shellfish (including clams mussels and oysters) should be collected or consumed from designated areas [MACTEC 2008a] Although under current conditions consumption of shellfish is not a completed pathway future land use of the area may change the situation
ATSDR used the US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) safety tolerance level for lead and the FDA total diet study results for element levels in market basket surveys for comparison The lead safety tolerance level of 17 milligrams per kilogram (mgkg) represents a point at or above which the FDA will take action
2
Callahan Mine Site Health Consultation
to remove products from the market [FDA 2001] The total diets study indicated that the maximum lead concentration found in the food we consume is 0026 mgkg [FDA 2006]
MACTEC Engineering and Consulting Inc personnel collected 24 pairs of clam and sediment samples from Goose Pond during the weeks of July 28 and August 4 2008 Each cooked clam tissue sample was analyzed twice once on August 14 2008 and once on August 15 2008 The average lead concentrations of the two runs (067- 28 mgkg) in cooked clam tissue samples were used in the IEBUK model The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008 and exceed the FDA safety tolerance level and the maximum value of lead found in the total diet study Therefore ATSDRrsquos conclusions and recommendations from the June 2008 health consultation remain the same specifically ATSDR finds that residents and visitors to the area should continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist
Child Health Considerations Children could be at greater risk than adults are after certain kinds of exposure to hazardous substances A childrsquos lower body weight results in a greater dose of hazardous substance per unit of body weight Children also are more active and have higher heart and respiratory rates causing them to have higher peak and mean exposures If toxic exposure levels are high enough during critical growth stages the developing body systems of children can sustain permanent damage Based on Callahan Mine site sampling data ATSDR considers that exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
Conclusions ATSDR reviewed the technical memorandum sections related to the use of the IEUBK model for lead risk evaluation ATSDR also reviewed the recent sampling data to determine whether people should not eat clams because of the lead levels in clams Based on the available information ATSDR reached the following conclusions
bull Exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
bull The levels of lead in cooked clam tissue samples exceeded the FDA safety tolerance level and the maximum value of lead found in the total diet study
bull The average levels of lead in cooked clam tissue samples from the site ranged from 067shy28 mgkg The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008
bull The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
3
Callahan Mine Site Health Consultation
Recommendations ATSDR recommends that individuals continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist in the area
4
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Callahan Mine Site Health Consultation
Statement of Issues On October 2 2008 the US Environmental Protection Agency (EPA) requested the Agency for Toxic Substances and Disease Registry (ATSDR) provide comments about the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model in a clam evaluation technical memorandum In light of new sampling data EPA has also requested ATSDR review the new data and advise on the relevance of the existing fish and shellfish consumption restrictions specifically whether those advisories should continue as currently issued This EPA request is being managed by ATSDR under the ldquoStrikerdquo process which is a rapid-response focused effort that does not include comprehensive review of the technical memorandum site contaminants and exposure pathways
Background The Callahan Mine site is located east-southeast of Harborside Village in the Town of Brooksville Hancock County Maine The site is the former location of a zinccopper open-pit mine The Callahan Mining Corporation operated the zinccopper mine at the site during 1881ndash 1887 and 1968ndash1972 The mine operated adjacent to and beneath Goose Pond a tidal estuary The property comprises 150 acres and is located in a coastal rural setting on the Cape Rosier peninsula The property abuts Goose Pond to the east and private properties to the west south and north The site consists of large waste piles (waste rock piles) a tailings pond and mine operations buildings and structures The open-pit mine flooded from a dam opening at Goose Falls in 1972 The mine is currently under water and is subject to daily tidal exchange in Goose Pond An interconnection exists between Goose Pond and Goose Cove to the north by a reversing falls known as Goose Falls Goose Cove is located on the southern part of Penobscot Bay
In September 2002 EPA added the site to the National Priorities List (NPL) Environmental sampling included soil sediment surface water groundwater seeps and biota from the site and surrounding areas A Draft Human Health Risk Assessment (HHRA) was completed and published in March 2008
In June 2008 ATSDR reviewed limited data provided by EPA to determine if people should not eat clams because of the lead levels in clams ATSDR concluded that levels of lead in sampled clams exceed the US Food and Drug Administration (FDA) safety tolerance level and the maximum value of lead found in the Total Diet Study ATSDR recommended that individuals continue to adhere to the existing fish and shellfish consumption restrictions and advisories in the area [ATSDR 2008]
Discussion ATSDR provides site-specific public health recommendations based on available toxicological literature levels of environmental contaminants detected at a site compared to accepted comparison values an evaluation of potential exposure pathways and the characteristics of the exposed population
According to the technical memorandum it is highly improbable that commercial clam harvesting would occur at Goose Pond because clams are not easily harvestable from the pond [MACTEC 2008b] The memorandum also concludes it is unlikely that recreational clam harvesting would occur in Goose Pond at least by local landowners who are familiar with the
1
Callahan Mine Site Health Consultation
area The memorandum states however that recreational clam harvesting by vacationers or new residents to the area might occur and that it is likely the frequency at which a single person would obtain clams from Goose Pond would be limited to only one or two meals per year and would not exceed five meals per year [MACTEC 2008b]
For this STRIKE request ATSDR reviewed the technical memorandum regarding the clam evaluation to provide comments about the use of the IEUBK lead model ATSDR also reviewed the recent sampling data to determine if people should not eat clams because of the lead levels in clams
ATSDRrsquos comments on the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model
In the technical memorandum preliminary remediation goals (PRGs) for lead in sediment that are protective for consumption of lead in clam tissue were calculated [MACTEC 2008b] PRGs were derived for the clam consumption scenarios that posed lead risks in excess of EPA risk management criteria using the IEUBK model
EPArsquos IEUBK model is the most common application used to estimate potential risk from exposure to lead The model is designed to integrate chronic and relatively stable exposures from lead in air water soil dust diet paint and other sources with pharmacokinetic modeling to predict blood lead concentrations in children 6 months to 7 years of age [EPA 1994] One limitation of the model is that it was not designed to assess short-term periodic or acute exposures The reliability of the model for predicting blood level concentrations for exposure durations shorter than 3 months has not been assessed If those intermittent exposures are time-averaged over the entire year the model may underestimate blood lead levels in children [EPA 2003 Lorenzana et al 2005] Because the focus of the model is children under age 7 model results will tend to over predict blood lead concentrations for older children and adults
The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
Clam tissue lead contamination evaluation
A potential human exposure pathway for this site is consuming contaminated biota such as clams harvested in the area Shell fish beds at and in the vicinity of the site are closed by the State and a shellfish ban is currently in effect for Goose Pond Goose Cove and other nearby areas The ban states that no shellfish (including clams mussels and oysters) should be collected or consumed from designated areas [MACTEC 2008a] Although under current conditions consumption of shellfish is not a completed pathway future land use of the area may change the situation
ATSDR used the US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) safety tolerance level for lead and the FDA total diet study results for element levels in market basket surveys for comparison The lead safety tolerance level of 17 milligrams per kilogram (mgkg) represents a point at or above which the FDA will take action
2
Callahan Mine Site Health Consultation
to remove products from the market [FDA 2001] The total diets study indicated that the maximum lead concentration found in the food we consume is 0026 mgkg [FDA 2006]
MACTEC Engineering and Consulting Inc personnel collected 24 pairs of clam and sediment samples from Goose Pond during the weeks of July 28 and August 4 2008 Each cooked clam tissue sample was analyzed twice once on August 14 2008 and once on August 15 2008 The average lead concentrations of the two runs (067- 28 mgkg) in cooked clam tissue samples were used in the IEBUK model The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008 and exceed the FDA safety tolerance level and the maximum value of lead found in the total diet study Therefore ATSDRrsquos conclusions and recommendations from the June 2008 health consultation remain the same specifically ATSDR finds that residents and visitors to the area should continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist
Child Health Considerations Children could be at greater risk than adults are after certain kinds of exposure to hazardous substances A childrsquos lower body weight results in a greater dose of hazardous substance per unit of body weight Children also are more active and have higher heart and respiratory rates causing them to have higher peak and mean exposures If toxic exposure levels are high enough during critical growth stages the developing body systems of children can sustain permanent damage Based on Callahan Mine site sampling data ATSDR considers that exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
Conclusions ATSDR reviewed the technical memorandum sections related to the use of the IEUBK model for lead risk evaluation ATSDR also reviewed the recent sampling data to determine whether people should not eat clams because of the lead levels in clams Based on the available information ATSDR reached the following conclusions
bull Exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
bull The levels of lead in cooked clam tissue samples exceeded the FDA safety tolerance level and the maximum value of lead found in the total diet study
bull The average levels of lead in cooked clam tissue samples from the site ranged from 067shy28 mgkg The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008
bull The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
3
Callahan Mine Site Health Consultation
Recommendations ATSDR recommends that individuals continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist in the area
4
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Callahan Mine Site Health Consultation
area The memorandum states however that recreational clam harvesting by vacationers or new residents to the area might occur and that it is likely the frequency at which a single person would obtain clams from Goose Pond would be limited to only one or two meals per year and would not exceed five meals per year [MACTEC 2008b]
For this STRIKE request ATSDR reviewed the technical memorandum regarding the clam evaluation to provide comments about the use of the IEUBK lead model ATSDR also reviewed the recent sampling data to determine if people should not eat clams because of the lead levels in clams
ATSDRrsquos comments on the use of the Integrated Exposure Uptake Biokinetic (IEUBK) lead model
In the technical memorandum preliminary remediation goals (PRGs) for lead in sediment that are protective for consumption of lead in clam tissue were calculated [MACTEC 2008b] PRGs were derived for the clam consumption scenarios that posed lead risks in excess of EPA risk management criteria using the IEUBK model
EPArsquos IEUBK model is the most common application used to estimate potential risk from exposure to lead The model is designed to integrate chronic and relatively stable exposures from lead in air water soil dust diet paint and other sources with pharmacokinetic modeling to predict blood lead concentrations in children 6 months to 7 years of age [EPA 1994] One limitation of the model is that it was not designed to assess short-term periodic or acute exposures The reliability of the model for predicting blood level concentrations for exposure durations shorter than 3 months has not been assessed If those intermittent exposures are time-averaged over the entire year the model may underestimate blood lead levels in children [EPA 2003 Lorenzana et al 2005] Because the focus of the model is children under age 7 model results will tend to over predict blood lead concentrations for older children and adults
The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
Clam tissue lead contamination evaluation
A potential human exposure pathway for this site is consuming contaminated biota such as clams harvested in the area Shell fish beds at and in the vicinity of the site are closed by the State and a shellfish ban is currently in effect for Goose Pond Goose Cove and other nearby areas The ban states that no shellfish (including clams mussels and oysters) should be collected or consumed from designated areas [MACTEC 2008a] Although under current conditions consumption of shellfish is not a completed pathway future land use of the area may change the situation
ATSDR used the US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) safety tolerance level for lead and the FDA total diet study results for element levels in market basket surveys for comparison The lead safety tolerance level of 17 milligrams per kilogram (mgkg) represents a point at or above which the FDA will take action
2
Callahan Mine Site Health Consultation
to remove products from the market [FDA 2001] The total diets study indicated that the maximum lead concentration found in the food we consume is 0026 mgkg [FDA 2006]
MACTEC Engineering and Consulting Inc personnel collected 24 pairs of clam and sediment samples from Goose Pond during the weeks of July 28 and August 4 2008 Each cooked clam tissue sample was analyzed twice once on August 14 2008 and once on August 15 2008 The average lead concentrations of the two runs (067- 28 mgkg) in cooked clam tissue samples were used in the IEBUK model The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008 and exceed the FDA safety tolerance level and the maximum value of lead found in the total diet study Therefore ATSDRrsquos conclusions and recommendations from the June 2008 health consultation remain the same specifically ATSDR finds that residents and visitors to the area should continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist
Child Health Considerations Children could be at greater risk than adults are after certain kinds of exposure to hazardous substances A childrsquos lower body weight results in a greater dose of hazardous substance per unit of body weight Children also are more active and have higher heart and respiratory rates causing them to have higher peak and mean exposures If toxic exposure levels are high enough during critical growth stages the developing body systems of children can sustain permanent damage Based on Callahan Mine site sampling data ATSDR considers that exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
Conclusions ATSDR reviewed the technical memorandum sections related to the use of the IEUBK model for lead risk evaluation ATSDR also reviewed the recent sampling data to determine whether people should not eat clams because of the lead levels in clams Based on the available information ATSDR reached the following conclusions
bull Exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
bull The levels of lead in cooked clam tissue samples exceeded the FDA safety tolerance level and the maximum value of lead found in the total diet study
bull The average levels of lead in cooked clam tissue samples from the site ranged from 067shy28 mgkg The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008
bull The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
3
Callahan Mine Site Health Consultation
Recommendations ATSDR recommends that individuals continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist in the area
4
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Callahan Mine Site Health Consultation
to remove products from the market [FDA 2001] The total diets study indicated that the maximum lead concentration found in the food we consume is 0026 mgkg [FDA 2006]
MACTEC Engineering and Consulting Inc personnel collected 24 pairs of clam and sediment samples from Goose Pond during the weeks of July 28 and August 4 2008 Each cooked clam tissue sample was analyzed twice once on August 14 2008 and once on August 15 2008 The average lead concentrations of the two runs (067- 28 mgkg) in cooked clam tissue samples were used in the IEBUK model The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008 and exceed the FDA safety tolerance level and the maximum value of lead found in the total diet study Therefore ATSDRrsquos conclusions and recommendations from the June 2008 health consultation remain the same specifically ATSDR finds that residents and visitors to the area should continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist
Child Health Considerations Children could be at greater risk than adults are after certain kinds of exposure to hazardous substances A childrsquos lower body weight results in a greater dose of hazardous substance per unit of body weight Children also are more active and have higher heart and respiratory rates causing them to have higher peak and mean exposures If toxic exposure levels are high enough during critical growth stages the developing body systems of children can sustain permanent damage Based on Callahan Mine site sampling data ATSDR considers that exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
Conclusions ATSDR reviewed the technical memorandum sections related to the use of the IEUBK model for lead risk evaluation ATSDR also reviewed the recent sampling data to determine whether people should not eat clams because of the lead levels in clams Based on the available information ATSDR reached the following conclusions
bull Exposures to lead contaminated clams could potentially result in harmful health effects in children if current fishing restrictions are lifted in the area
bull The levels of lead in cooked clam tissue samples exceeded the FDA safety tolerance level and the maximum value of lead found in the total diet study
bull The average levels of lead in cooked clam tissue samples from the site ranged from 067shy28 mgkg The maximum lead concentration in cooked tissue was 374 mgkg in a single run Those levels are within the same order of magnitude as the data ATSDR reviewed in June 2008
bull The decision to use the IEUBK model to determine PRGs is a regulatory decision and beyond the scope of ATSDRrsquos public health evaluation of the site-specific exposure scenario ATSDR understands that when deriving site-specific PRGs for lead EPA also considers aspects such as site-specific variability in exposure lead geochemistry and projected land use EPA may also factor in other considerations such as cost technical feasibility compliance with state and federal regulations and community acceptance
3
Callahan Mine Site Health Consultation
Recommendations ATSDR recommends that individuals continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist in the area
4
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Callahan Mine Site Health Consultation
Recommendations ATSDR recommends that individuals continue to adhere to the fish and shellfish consumption restrictions and advisories that already exist in the area
4
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Callahan Mine Site Health Consultation
Prepared by
Jane Zhu DMD MPH Environmental Health Scientist Exposure Investigation and Consultation Branch Division of Health Assessment and Consultation
Reviewed by
Tarah Somers RN MSNMPH Lieutenant Commander US Public Health Service Division of Regional Operations Region I
Danielle Langmann MS Strike Team Lead Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Don Joe PE Acting Deputy Branch Chief Exposure Investigation and Site Assessment Branch Division of Health Assessment and Consultation
Daphne Moffett PhD Commander US Public Health Service Associate Director of Science Division of Health Assessment and Consultation
5
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Callahan Mine Site Health Consultation
References
[ATSDR] Agency for Toxic Substances and Disease Registry 2008 Public health consultation Callahan Mining Corporation Brooksville (Cape Rosier) Hancock County Maine Atlanta US Department of Health and Human Services
[EPA] US Environmental Protection Agency 1994 Guidance manual for the integrated exposure uptake biokinetic model for lead in children NTIS PB93-963510 EPA 92857-15-1 Washington DC Office of Solid Waste and Emergency Response
[EPA] US Environmental Protection Agency 2003 Assessing intermittent or variable exposures at lead sites EPA-540-R-03-008 OSWER 92857-76 Washington DC Office of Solid Waste and Emergency Response Available at httpwwwepagovsuperfundhealthcontaminantsleadproductstwa-final-Nov2003pdf
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2001 Fish and fisheries products hazards and controls guidance Third Edition College Park Maryland Available at httpwwwcfsanfdagov~commhaccp4x5html
[FDA] The US Food and Drug Administration Center for Food Safety and Applied Nutrition 2006 Total diet study statistics on element revision 4 market baskets 1991-3 through 2004-4 College Park Maryland August 21 2006
Lorenzana R Troast R Follansbee M and Diamond G 2005 Issues related to time averaging of exposure on modeling risk associated with intermittent exposures to lead Risk Analysis Vol25 No1 (169-178)
[MACTEC] MACTEC Engineering and Consulting Inc 2008a Draft human health risk assessment Volume II of III Augusta ME Maine Department of Transportation
[MACTEC] MACTEC Engineering and Consulting Inc 2008b Technical memorandum clam tissue and sediment sampling bioaccessibility study and risk evaluation Callahan Mine Superfund Site Brooksville Maine Project No 3612062047 September 2008
6
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
Certification
This Callahan Mine Superfund Site Health Consultation was prepared by the federal Agency for Toxic Substances and Disease Registry (ATSDR) It was completed in accordance with approved methodologies and procedures existing at the time the health consultation was initiated
The Division of Health Assessment and Consultation (DHAC) and Division of Regional Operations (DRO) ATSDR have reviewed this health consultation and concur with its findings
Tarah Somers DRO ATSDR
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