New Study Shows the FDA Got It Wrong: Despite the Agency’s “All Clear,” Gulf Seafood Isn’t Safe to Eat

I’ve said it until I’m blue in the face. I’ve shouted it from the rooftops: Beware, the testing program the federal government uses to determine the safety of Gulf seafood is a complete sham. The testing methodology – which at one point consisted of simply “sniffing” the samples – sets ridiculously low consumption levels and accepts as “safe” dangerously high levels of contamination. That’s a one-two punch that puts the public, particularly Gulf Coast residents, at increased risk for cancer and other debilitating illnesses and conditions.

I and other blue-faced critics of the FDA’s “all clear” just got a shot in the arm with the release last week of a new study from the Natural Resources Defense Council (NRDC) that exposes the failings of the government testing program and warns the public about the very real risks tied to the consumption of Gulf seafood (see link to study below).

So despite the green light from the FDA, consider this from an Oct. 14 TIME Magazine report before you belly back up to the raw bar:

…an environmental watchdog group says the agency’s standards are “based on outdated science” and underestimate the risk of cancer-causing contaminants to pregnant women and children eating seafood from the Gulf.

At issue are what the FDA considers safe levels of polycyclic aromatic hydrocarbons (PAHs), compounds found in oil, coal and gasoline that have been linked to cancer in animals and humans. According to Miriam Rotkin-Ellman, a researcher with the Natural Resources Defense Council (NRDC), the FDA accepts 100 to 10,000 times more PAH contamination in seafood than the NRDC deems safe for vulnerable populations.

That conclusion was published online Wednesday in the journal Environmental Health Perspectives. On the same day, the NRDC filed a petition asking the FDA to reevaluate its science and set new limits for PAHs in seafood to ensure public safety, especially for vulnerable populations like pregnant women and children.

Big kudos to Ms. Rotkin-Ellman and the NRDC for staying on top of this hugely important public health issue – and pushing the government to ensure the safety of its citizens. The health of our families, friends and neighbors is at stake.

The TIME article goes on to cite the considerable flaws of the FDA’s testing program, which mirror the concerns and issues my research team has been confronting for months:

On her blog, Rotkin-Ellman noted “six major flaws” in the FDA’s assessment of PAHs in Gulf seafood: “assuming everyone weighs 80 kg (176 lbs), underestimating how much seafood Gulf residents eat, ignoring the cancer risk from naphthalene [a common PAH] contamination, failing to address the increased vulnerability of pregnant women and children, allowing for a high level of cancer risk, and assuming that the contamination will only last five years.”

Rotkin-Ellman provides chilling data on the increased cancer risk posed to our most vulnerable populations:

According to our calculations, the risk of cancer associated with eating Gulf shellfish contaminated at the levels FDA says is safe could be as high as 20,000 in a million. Put another way, this means that if 1,000 pregnant women (and their children) ate Gulf seafood contaminated at the levels FDA said are safe, 20 of the children born to them would be at significant risk of cancer from the contamination.

Obviously, this level of risk is completely unacceptable. The fact that the federal government has put political considerations before the safety of the public – particularly women and children – is unconscionable.

Veteran toxicologist Dr. William Sawyer, a leading member of my research team, has been highly critical of the FDA’s half-baked testing program since its inception last year:

Unfortunately, FDA missed the boat on this one and specifically substituted unfounded and novel methodology in the calculation of human health risks. The agency actually deviated from generally accepted methods which were historically developed by the National Academy of Science, USEPA and even their own agency.

For example, only adult body weights were used in their assessment rather than the conventional aggregate body weight for children from 6 years to age 30 years at 52 kg.  Ignoring children, teens and young adults from ages 6 to 30 and only including high mass, overweight adults at 80 kg effectively “hides” the apparent level of risk due to the way in which the risk calculation functions. That is, higher body mass leads to a proportionally lower dose. Additionally, the risk adjustment for children, who are more sensitive to the mutagenic effects of these chemicals, is conveniently ignored.

FDA also failed to acknowledge studies documenting much higher levels of seafood consumption in Gulf Coast localities. Thus, the input quantity into the risk calculation is erroneous. The FDA also “relaxed” the cancer benchmark level of one cancer per million to ten cancers per million citing two very small oil spills where this substitution was used. However, these other two oil spills occurred in a small fishery where only a relatively very small number of seafood consumers could have been exposed. In the current matter, tens of millions of seafood consumers are potentially impacted as the Gulf of Mexico is by far the largest single source of seafood in the United States.

So we’ve determined that the FDA’s testing is deeply flawed. Now the question becomes: How much tainted seafood is out there that could possibly get into the food chain? Consider this from my Feb. 19, 2011, post:

On this blog, I’ve posted a series of lab-certified test results showing high levels of contamination (i.e., toxins associated with oil and/or dispersants) in seafood samples of every stripe, from royal red shrimp to blue crabs to red snapper. The research of one of my clients, the Louisiana Environmental Action Network (LEAN), is featured in a recent (Feb. 8, 2011) Huffington Post article by Susan Buchanan entitled “Private Seafood Tests Uncover Toxins Missed By Feds.” The article cites Paul Orr of the Lower Mississippi River-keeper in Baton Rouge (the parent organization is LEAN):

Oysters, crabs and fin fish were gathered from twenty locations between the western edge of Terrebonne Parish and the Louisiana-Mississippi border. They were tested for total petroleum hydrocarbons or TPHs and polycyclic aromatic hydrocarbons or PAHs. Testing was done by two, commercial-lab companies, using EPA-recognized protocols, Orr said.

“All of the seafood organisms that we collected came back with TPH levels that were of concern to us, and a number of them were very, very high,” Orr said. “As far as we can determine after talking with researchers and a toxicologist, there should be no detectable levels of TPH in seafood. We also found some high levels of total PAH’s.”

Orr continued, saying “some of the organisms we tested came from waters that were open for fishing, and the samples all looked beautiful. They smelled good, and there was nothing that made me think that they might be contaminated with oil.”

Orr doubted anything would be found in the first oyster samples that the group sent for testing. “But they came back from the lab containing 9,780 mg/kg of total petroleum hydrocarbons, which was a bit alarming. Since then, we’ve sampled from the western edge of Terrebonne Parish to the Louisiana-Mississippi line, and the results we got back suggest to me that the government’s ‘all clear’ was sounded far too soon.”

The HuffPo piece also covers the work of Peter Brabeck, an environmental monitor at the nonprofit Louisiana Bucket Brigade:

“…we received test results a week ago from samples of oysters collected in Terrebonne Bay and Grand Bayou Felicity in Lafourche Parish.” Those samples were tested by a Wisconsin lab run by Pace Analytical Services, which also has a sediment-and-water lab in St. Rose, La. The Bucket Brigade sent three, separate samples to Wisconsin, where they were chemically tested in batches of 7 to 9 oysters each.

“To my horror, the results showed extremely elevated levels of cadmium – which is associated with oil from the BP spill,” Brabeck said. The cadmium detected was 150 to 200 times what’s considered safe for human consumption by the Environmental Protection Agency’s carcinogenicity ‘RfD’ or oral reference doses for food, he said.

As a native son of Louisiana and a New Orleans resident, I love Gulf seafood and fully realize what it means to our economy and our culture. I miss it. But independent testing by highly qualified scientists – most recently seen in the NRDC study – is troubling to say the least.

The “seafood safety” debate has been boiling for some time now, but the overwhelming evidence calling for caution is leaving the FDA nowhere to hide. The agency must immediately, as the NRDC has petitioned, “reevaluate its science and set new limits for PAHs in seafood to ensure public safety.” Anything less amounts to a violation of the FDA’s mission to ensure the safety of the citizens of the United States.

Read the TIME report in its entirety: http://healthland.time.com/2011/10/14/study-gulf-seafood-unsafe-for-pregnant-women-and-children/#ixzz1b2lK4InZ

Review the NRDC study here: http://ehp03.niehs.nih.gov/article/info%3Adoi%2F10.1289%2Fehp.1103695#abstract0

Read how “seafood safety” concerns intensified late last year and how we challenged the government’s “all clear” declaration: https://www.stuarthsmith.com/mainstream-media-challenge-governments-all-clear-on-seafood-safety

Read an MSNBC report on our challenge to the FDA’s testing program: http://www.msnbc.msn.com/id/40494122/ns/us_news-environment/t/panel-challenges-gulf-seafood-safety-all-clear/

View a KLFY Eyewitness News report on elevated levels of toxic chemicals found in seafood and the blood of Gulf residents: https://www.stuarthsmith.com/featured-video-enviro-group-releases-alarming-test-results-on-human-health-effects-and-seafood-safety

Read my previous post on alarmingly high levels of contamination found in red snapper: https://www.stuarthsmith.com/exclusive-test-results-red-snapper-sample-from-off-pensacola-shows-dangerously-high-levels-of-contamination-%E2%80%93-nearly-3000-ppm-of-total-petroleum-hydrocarbons

Catchup on what independent seafood testing has revealed at HuffPo: http://www.huffingtonpost.com/susan-buchanan/private-seafood-tests-unc_b_820002.html

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