FDA's Bad Science: Agency Allows Unsafe Levels of Contaminants in Seafood


Is the Food and Drug Administration (FDA) looking out for your health? Not nearly enough, according to our new study published today in the scientific journal Environmental Health Perspectives. That’s especially true for young children and pregnant women, as well as anyone who eats a lot of seafood. We found that FDA’s calculation of allowable levels of contaminants in seafood, after BP's 2010 Gulf of Mexico oil spill, was based on outdated science. As a result, FDA’s “safe levels” were not safe for vulnerable populations because they allowed up to 10,000 times too much cancer-causing polycyclic aromatic hydrocarbons (PAHs) contamination in Gulf seafood.

Unfortunately, FDA’s reliance upon outdated science is not an isolated incident. The agency’s flawed assessment, monitoring and regulation of numerous chemicals exposes us to unnecessary and dangerous amounts of chemicals in our food and household products.

It’s time to change that.

NRDC filed a petition today with FDA demanding that the agency recognize the hazards posed by PAHs in seafood and set a health protective standard.  This petition calls for FDA to update its science and fix how it assesses the threat of chemical contaminants so we can trust the safety of our food supply.

My colleague, Dr. Gina Solomon, and I blogged over the past year on the six major flaws in FDA’s risk assessment of PAHs in Gulf seafood: assuming everyone weighs 80kg (176 lbs), underestimating how much seafood Gulf residents eat, ignoring the cancer risk from naphthalene 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

This was an unrealistic and outdated assessment, which greatly underestimated the risks from PAH contaminated seafood, particularly for pregnant women and children that eat a lot of seafood.  For our study, we used the most current science and more realistic assumptions - including a separate and tailored assessment of the risks for pregnant women and young children, seafood consumption numbers that better reflect the diets of Gulf residents, and made sure to follow the determination of the National Toxicology Program and the State of California which say that naphthalene can cause cancer - and did our own calculations on the allowable levels of contaminants in seafood. We were surprised by how far off FDA’s numbers really were. FDA accepted 100 to 10,000 times more PAH contamination of seafood than our calculations deemed safe.

For example , FDA said that 123,000 micrograms of naphthalene per kilogram of shrimp was safe for everyone to eat.  According to our calculations, only 5.91 micrograms should have been allowed to protect pregnant women and children who eat a lot of seafood.  For comparison, our calculations show that 46.99 micrograms of naphthalene per kilogram of shellfish would be safe for an adult consumer.

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.  This is not public health protection. Major reforms are needed at FDA to better safeguard our food supply.

When we looked carefully at the available testing data on PAH levels in shellfish after the spill, we found that FDA’s claim that there were no health risks from eating Gulf seafood was inaccurate. Up to 53 percent of the shrimp tested had PAH levels exceeding our revised levels of concern for pregnant women who eat a lot of Gulf shellfish.

Instead of saying it was safe for everyone to eat, pregnant women and children should have been warned and advised to reduce their Gulf shellfish consumption.

We have been concerned about this for a while. When FDA published its levels of concern last year after the oil spill, as part of the protocol for determining when it was safe to resume fishing in the Gulf, I scoured the document trying to understand how FDA could have overlooked the science on how to protect vulnerable populations from contaminants in seafood. That document provided no justification for why FDA’s analysis differed from the guidelines of other agencies and even from FDA’s own prior practice after other oil spills.  What was going on? To get to the bottom of this, we requested documents from FDA under the Freedom of Information Act (FOIA). What we found shouldn’t have surprised me. 

After more than a year of wrangling to get the right documents, through the FOIA request we learned that the Environmental Protection Agency, and even some FDA staff, proposed stronger health protections from contamination but were ignored.

EPA scientists warned the FDA in an email that it underestimated risks for many seafood consumers, particularly Gulf Coast residents.

FDA staff also reviewed multiple values for its risk assessment calculations and found many of them to be legitimate approaches, but did not pursue them further. Tables included in emails among FDA staff received in the FOIA documents, look at allowable levels of contaminants using different combinations of assumptions.  FDA considered setting the limit for benzo(a)pyrene in shrimp at 3 parts per billion (ppb) to 170 ppb, with many options in between. FDA’s final number was 132 ppb but based on our calculations, to protect pregnant women and kids the number should have been 0.1 ppb. It’s interesting to note that the low end of its initial range isn’t that far off from what we calculated. 

Early in the process, an FDA staffer proposed considering the possibility that people don’t just eat one kind of Gulf seafood. Somehow, that common sense thinking got lost along the way and FDA instead chose numbers that were not scientifically justifiable and not health protective.

Common sense seems to be missing elsewhere too and this dizzying list of tables, permutations, and values from FDA’s process begs the question: What is FDA’s standard practice for conducting risk assessments and determining safer levels of chemical contaminants in food?   The answer:  There doesn’t appear to be one.

As a result, FDA officials set levels of acceptable PAHs in seafood on a case-by-case basis after every oil spill resulting in numbers that vary by orders of magnitude.  This is unacceptable and we want FDA to set a consistent standard for PAHs in seafood. 

We rely on the FDA to safeguard the health of our families and ensure the safety of the food on our tables and the products in our home. The findings of our study on Gulf seafood along with FDA’s failure to regulate antibiotics in livestock, endocrine disrupting chemicals in food additives and toxic chemicals in hand soaps and personal care products is evidence that FDA is falling down on the job.  We shouldn't wait for people to get sick or cancer rates to rise, we need FDA to act now to protect the health of all Americans.

For more information on how to fix FDA check out our website: www.nrdc.org/fixfda.


Photo of shrimp from the Gulf taken October 2010 by Lisa Whiteman