FDA not only downplayed the risk of contamination, but ignored staff members who proposed higher levels of contamination protection.
By Brad Jacobson, AlterNet
Ever since the largest offshore oil spill in history spewed into the Gulf of Mexico last year, independent public health experts have questioned the U.S. Food and Drug Administration's efforts to effectively protect Americans from consuming contaminated seafood.
Now a recent study by two of the most tenacious non-government scientists reveals that FDA Gulf seafood "safe levels" allowed 100 to 10,000 times more carcinogenic polycyclic aromatic hydrocarbons (PAHs) in seafood than what is safe. The overarching issue the report addresses is the failure of the FDA's risk assessment to protect those most vulnerable to the effects of these chemicals, such as young children, pregnant women and high-consumption seafood eaters.
In an effort to pinpoint how the FDA decided to set its acceptable levels for PAH contaminants in Gulf seafood, researchers at the Natural Resources Defense Council, which performed the study -- published in the leading peer-reviewed environmental health journal Environmental Health Perspectives -- also scoured documents wrested from the FDA under the Freedom of Information Act.
These include internal emails and unreleased assessments that suggest the FDA not only downplayed the risk of contamination but also that the EPA, and even members of FDA staff, had proposed higher levels of contamination protection, which in the end were ignored.
In vehemently denying the NRDC study's findings, the FDA argues that its chemical risk assessments are inherently biased "on the side of safety" and that setting higher protective health measures for PAHs in Gulf seafood would actually "do more harm than good."
Robert Dickey, director of the FDA's Gulf Coast Seafood Laboratory, who's taken the lead for the agency in responding to the NRDC report, elaborated in an email to AlterNet, "Overly conservative estimates would lead you [to] remove a great deal of food from our refrigerators and pantries than is needed."
In an interview with AlterNet, the study's lead researcher, NRDC staff scientist Miriam Rotkin-Ellman, said that such a response from the FDA "begs the question of whether or not it was a political versus a scientific decision" because the agency "does not provide scientific evidence" for the claim that being more health protective somehow carries an increased risk of doing harm.
She added, "PAHs in food have been evaluated and standards set in the European Union without jeopardizing anyone's nutrition."
AlterNet confirmed that the FDA indeed has provided no scientific evidence to back up this claim in either its formal response to the NRDC report or in addressing AlterNet's questions.
More broadly, the FDA declined to directly explain the email correspondence the study's researchers obtained in the FOIA request. They reveal that the Environmental Protection Agency, and even members of the FDA's own staff, questioned the FDA's seafood safety risk assessment criteria for protecting the most vulnerable populations, particularly Gulf residents.
Other documents received via the FOIA request show that the FDA considered multiple other potential calculations and criteria where more health protective risk assessments were considered but never followed.
Asked if these documents, along with the NRDC study's findings, belie the FDA's chief claim that their risk assessments are biased "on the side of safety," Dickey responded, "The seafood safety risk assessment was developed in extensive and open collaboration between FDA, EPA, CDC, NOAA, and public health experts and toxicologists from all five Gulf states impacted by the oil spill."
He added, "During that process many factors and calculations were considered before the final version was agreed on by all participants."
Dickey also claims that the FDA has "built into our assessments, a more than 100-fold safety factor that gives us confidence that sensitive populations are protected."
Yet Rotkin-Ellman countered that this conclusion is based on "outdated science" in which FDA calculations relied on the average lifetime weight of a 176-pound person.
"FDA continues to ignore the best scientific evidence on early-life vulnerability to chemical contaminants, which has shown that it is not sufficient to rely on life-time assessments," she said.
"The National Academy of Sciences and EPA guidelines emphasize that additional steps must be taken to specifically assess early-life stages," Rotkin-Ellman continued, "which includes calculating exposure based on age-specific bodyweights and adjusting to account for increased susceptibility."
The NRDC study found, for example, that the risk of cancer associated with eating Gulf shellfish contaminated at levels the FDA has deemed safe could be as high as 20,000 in a million. In other words, if 1,000 pregnant women consumed Gulf seafood at these levels, 20 of the children they give birth to would be at significant risk of cancer from the contamination.
The report also concluded that based on available testing data on PAH levels in shellfish after the spill, up to 53 percent of the shrimp tested had PAH levels exceeding the NRDC researchers' revised levels of concern for pregnant women who are high consumers of Gulf shellfish.
In the interview with Rotkin-Ellman, she highlighted many other central weaknesses in the FDA's protective criteria for PAHs in Gulf seafood about which she and her NRDC study co-author and UCSF clinical professor of health sciences, Gina Solomon, have long been concerned. These include underestimating the amount of seafood Gulf residents consume, ignoring cancer risk from naphthalene contamination (one of the most prevalent PAHs in petroleum) and projecting the contamination will only last five years.
Another key finding the NRDC report confirmed is that the FDA has no set levels of acceptable PAHs in seafood, but rather creates them on a case-by-case basis after each oil spill.
For example, the FDA made PAH "safe levels" less stringent after the BP oil spill than they had been following the Exxon-Valdez spill.
Asked to explain this practice, Dickey replied, "Each oil spill can involve different kinds of crude oils or refined oil products in different types of environments, so the responses are different to account for the physical environment and the compounds of concern that must be tested for."
He added, "Also, over time scientific knowledge of the toxicity of the many hundreds to thousands of compounds in oil and refined oil products increases, which directly affects the analysis of risks involved."
But Rotkin-Ellman noted his answer simply evades the underlying question.
"There are core PAHs of public health concern that are present in most petroleum products that FDA could set standards for regardless of the specifics of an oil spill," she said. "If analyses prove that those PAHs are not present in the next oil spill then those standards will not be applicable."
But this variability, she went on to say, does not preclude FDA from evaluating health threats from PAHs now.
"The ad-hoc risk assessment performed by FDA without public or outside expert review," Rotkin-Ellman added, "have jeopardized FDA's credibility and they have lost public confidence."
Currently, the FDA has no plans to begin setting standard levels of concern for PAHs in U.S. seafood, as Europe does to protect its citizens. The NRDC recently filed a petition with the FDA to change this practice but has yet to receive a response.
Gulf seafood continues to be tested on a limited basis.
On the FDA's Web site, the agency contends that seafood from the Gulf "is as safe to eat as it was before the oil spill."
By Brad Jacobson, AlterNet
Posted on December 18, 2011
Ever since the largest offshore oil spill in history spewed into the Gulf of Mexico last year, independent public health experts have questioned the U.S. Food and Drug Administration's efforts to effectively protect Americans from consuming contaminated seafood.
Now a recent study by two of the most tenacious non-government scientists reveals that FDA Gulf seafood "safe levels" allowed 100 to 10,000 times more carcinogenic polycyclic aromatic hydrocarbons (PAHs) in seafood than what is safe. The overarching issue the report addresses is the failure of the FDA's risk assessment to protect those most vulnerable to the effects of these chemicals, such as young children, pregnant women and high-consumption seafood eaters.
In an effort to pinpoint how the FDA decided to set its acceptable levels for PAH contaminants in Gulf seafood, researchers at the Natural Resources Defense Council, which performed the study -- published in the leading peer-reviewed environmental health journal Environmental Health Perspectives -- also scoured documents wrested from the FDA under the Freedom of Information Act.
These include internal emails and unreleased assessments that suggest the FDA not only downplayed the risk of contamination but also that the EPA, and even members of FDA staff, had proposed higher levels of contamination protection, which in the end were ignored.
In vehemently denying the NRDC study's findings, the FDA argues that its chemical risk assessments are inherently biased "on the side of safety" and that setting higher protective health measures for PAHs in Gulf seafood would actually "do more harm than good."
Robert Dickey, director of the FDA's Gulf Coast Seafood Laboratory, who's taken the lead for the agency in responding to the NRDC report, elaborated in an email to AlterNet, "Overly conservative estimates would lead you [to] remove a great deal of food from our refrigerators and pantries than is needed."
In an interview with AlterNet, the study's lead researcher, NRDC staff scientist Miriam Rotkin-Ellman, said that such a response from the FDA "begs the question of whether or not it was a political versus a scientific decision" because the agency "does not provide scientific evidence" for the claim that being more health protective somehow carries an increased risk of doing harm.
She added, "PAHs in food have been evaluated and standards set in the European Union without jeopardizing anyone's nutrition."
AlterNet confirmed that the FDA indeed has provided no scientific evidence to back up this claim in either its formal response to the NRDC report or in addressing AlterNet's questions.
More broadly, the FDA declined to directly explain the email correspondence the study's researchers obtained in the FOIA request. They reveal that the Environmental Protection Agency, and even members of the FDA's own staff, questioned the FDA's seafood safety risk assessment criteria for protecting the most vulnerable populations, particularly Gulf residents.
Other documents received via the FOIA request show that the FDA considered multiple other potential calculations and criteria where more health protective risk assessments were considered but never followed.
Asked if these documents, along with the NRDC study's findings, belie the FDA's chief claim that their risk assessments are biased "on the side of safety," Dickey responded, "The seafood safety risk assessment was developed in extensive and open collaboration between FDA, EPA, CDC, NOAA, and public health experts and toxicologists from all five Gulf states impacted by the oil spill."
He added, "During that process many factors and calculations were considered before the final version was agreed on by all participants."
Dickey also claims that the FDA has "built into our assessments, a more than 100-fold safety factor that gives us confidence that sensitive populations are protected."
Yet Rotkin-Ellman countered that this conclusion is based on "outdated science" in which FDA calculations relied on the average lifetime weight of a 176-pound person.
"FDA continues to ignore the best scientific evidence on early-life vulnerability to chemical contaminants, which has shown that it is not sufficient to rely on life-time assessments," she said.
"The National Academy of Sciences and EPA guidelines emphasize that additional steps must be taken to specifically assess early-life stages," Rotkin-Ellman continued, "which includes calculating exposure based on age-specific bodyweights and adjusting to account for increased susceptibility."
The NRDC study found, for example, that the risk of cancer associated with eating Gulf shellfish contaminated at levels the FDA has deemed safe could be as high as 20,000 in a million. In other words, if 1,000 pregnant women consumed Gulf seafood at these levels, 20 of the children they give birth to would be at significant risk of cancer from the contamination.
The report also concluded that based on available testing data on PAH levels in shellfish after the spill, up to 53 percent of the shrimp tested had PAH levels exceeding the NRDC researchers' revised levels of concern for pregnant women who are high consumers of Gulf shellfish.
In the interview with Rotkin-Ellman, she highlighted many other central weaknesses in the FDA's protective criteria for PAHs in Gulf seafood about which she and her NRDC study co-author and UCSF clinical professor of health sciences, Gina Solomon, have long been concerned. These include underestimating the amount of seafood Gulf residents consume, ignoring cancer risk from naphthalene contamination (one of the most prevalent PAHs in petroleum) and projecting the contamination will only last five years.
Another key finding the NRDC report confirmed is that the FDA has no set levels of acceptable PAHs in seafood, but rather creates them on a case-by-case basis after each oil spill.
For example, the FDA made PAH "safe levels" less stringent after the BP oil spill than they had been following the Exxon-Valdez spill.
Asked to explain this practice, Dickey replied, "Each oil spill can involve different kinds of crude oils or refined oil products in different types of environments, so the responses are different to account for the physical environment and the compounds of concern that must be tested for."
He added, "Also, over time scientific knowledge of the toxicity of the many hundreds to thousands of compounds in oil and refined oil products increases, which directly affects the analysis of risks involved."
But Rotkin-Ellman noted his answer simply evades the underlying question.
"There are core PAHs of public health concern that are present in most petroleum products that FDA could set standards for regardless of the specifics of an oil spill," she said. "If analyses prove that those PAHs are not present in the next oil spill then those standards will not be applicable."
But this variability, she went on to say, does not preclude FDA from evaluating health threats from PAHs now.
"The ad-hoc risk assessment performed by FDA without public or outside expert review," Rotkin-Ellman added, "have jeopardized FDA's credibility and they have lost public confidence."
Currently, the FDA has no plans to begin setting standard levels of concern for PAHs in U.S. seafood, as Europe does to protect its citizens. The NRDC recently filed a petition with the FDA to change this practice but has yet to receive a response.
Gulf seafood continues to be tested on a limited basis.
On the FDA's Web site, the agency contends that seafood from the Gulf "is as safe to eat as it was before the oil spill."
No comments:
Post a Comment