Will A BRAWM Member explain...

While the reported Cs137 contamination levels are low, don't fool yourself by relying on the FDA DIL as some threshold, beneath which all foods are deemed "safe for consumption." It is not, nor is it intended to indicate food safety. The following is the best investigative research I've seen on this topic (by chargirl, on page 3 of comments to Jeff McMahon, "Forbes.com," article from April, 2011: http://www.forbes.com/sites/jeffmcmahon/2011/04/10/epa-new-radiation-hig...

"Please note that the FDA explicitly states that its DILs are not health safety standards. See their FAQ at http://www.fda.gov/newsevents/publichealthfocus/ucm247403.htm. They are rules for when it will exercise its authority to prohibit the sale of particular products.

In answering the hypothetical FAQ “What are the standards for radionuclides in foods?” the FDA states that its organization has set Derived Intervention Levels (DILs) for foods but that their DILs “do not define a safe or unsafe level of exposure.”

Instead, they represent “a level at which protective measures would be recommended to ensure that no one receives a significant dose.” Obvious questions: What does “significant dose” mean? Why should “significant” take the place of “dangerous”? A reasonable person reading this might ask: what’s the point, if it’s not a safety standard? Well, the DILs are described by the FDA as “guidance levels,” suggesting that they exist to give the agency guidance as to when to exercise its admittedly large power to stop the commercial sale of goods (an action, by the way, for which they can be sued). Is cost to the economy or particular industries one part of the DIL risk calculation? I hazard the FDA Food Safety chief Michael Taylor (who when not at the FDA has spent his career as a lawyer and lobbyist for, and executive at, Monsanto) doesn’t want to jump to quarantine thousands of kgs of eggs, cheese and milk (not to mention dispose of them as radioactive waste, which they would be required to do), and the USDA doesn’t want to tell farmers to shelter their cows and feed them more expensively on silage instead of (free) grass.

The FDA’s public FAQs do not reveal how the DILs were derived, nor what makes a dose “significant” as opposed to “unsafe.” However, they do show the FDA is making some assumptions (which it describes, without discussion, as “conservative.” Of course to an individual concerned with his or her family’s safety, this is simply reassurance, not information), which should be clearly and publicly set forth in the FAQ: 1) “the percentage of the diet assumed to be contaminated,” 2) “the amount of food consumed” and 3) “the length of time an individual consumes contaminated food.” Other relevant assumptions probably include: the age, sex and weight of the individual upon whom the risk analysis is based, whether the intervention levels change based on the age or weight of the individual, and the level of radiation that the individual is otherwise presumed to be exposed to (i.e., aside from the food-borne radiation – Is the individual drinking contaminated water? Is he breathing in contaminated air?)

Several things lead me to doubt that the FDA’s use of DILs to reassure the public of the ‘safety’ of the U.S. food supply is purely based on human health, or is sufficiently protective of my health:

• EPA’s general position for decades has been to regulate exposures to keep the risk to the public at one cancer in one million people. The FDA’s DILs allow a fatal cancer incidence increase of 1 in 4400. See http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Chemical... (“For 5 mSv committed effective dose equivalent (the PAG adopted in the new CPG), the associated lifetime total cancer mortality would be 2.25 x 10-4 or approximately 1 in 4400.”). That is, given a city like Seattle (3.4 million in the metro area), the FDA’s DILs would permit 772 people to die. In California, a state of over 37 million, 8,409 people would die of cancer. In the entire U.S. (over 308 million people), the DILs allow for 70,000 to die of cancer. In my opinion, that is far too many – even if we are just talking about a city like Seattle. The rate of non-fatal cancers instigated by radiation is generally 1 for each fatal cancer (a sensible rule-of-thumb to apply here, since I-131 causes thyroid cancer which from what I’ve read is rarely fatal). So when non-lethal cancers are included, the DILs also predictably allow for the creation of twice these numbers: i.e., 1544 in Seattle, 16,818 in California, and 140,000 in the U.S.

• Far from having determined that radioactive doses below this level are safe for human consumption, the FDA – as have many, many other federal agencies and scientific association – acknowledges that “Studies of human populations exposed at low doses are inadequate to demonstrate the actual magnitude of risk. There is scientific uncertainty about cancer risk in the low-dose region below the range of epidemiological observation, and the possibility of no risk cannot be excluded (CIRRPC 1992).” http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Chemical... And yet during the current crisis, the FDA has repeatedly led journalists and the public to conclude that the levels we’re seeing have been determined to be ‘safe.’

• The new guidance levels for the FDA assume that only 30% of the food supply has contamination, and that it is contaminated only for one year. http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Chemical.... This is not, as the FDA has described in its FAQs, a ‘conservative’ assumption. Milk, meat, eggs, and fresh produce could easily form much more than 30% of a healthy American diet. Cesium has a half-life of 30 years. It is noteworthy that the FDA states that its decision to reduce the percentage of the food supply is the main reason that the current DILs are higher than the standards the FDA had issued in 1986. The FDA’s new standards also use different dose values for intervention levels, dose coefficients, and food intake estimates.

• The FDA’s “derived intervention level” — the point at which steps would be taken to stop the sale of any particular food — is vastly above the EPA’s health-based standards, or Euratom’s health-based standards (which are referenced in the article on CRIIRAD Mothra provided above). The FDA allows exposures to 1200 Bq (33,000 pCi)/kg for the combined cesium isotopes, and 170 Bq (4,700 pCi)/kg for iodine-131. EPA’s standard is 3 pCi/L, or 700 pCi per year. One kg of cesium- or iodine-contaminated milk, going by the FDA standards, would greatly exceed EPA’s yearly maximum for ingestion from liquids.

• Despite UC Berkeley’s test results showing contamination of topsoil and food, the FDA does not appear to be doing any testing of U.S. food products for radiation that has been deposited from Japan, and is only focusing on imported foods. See http://www.fda.gov/newsevents/publichealthfocus/ucm247403.htm. The FDA’s FAQ on Fukushima radiation directs people to EPA’s website for any monitoring information – but the EPA is not monitoring food. So despite claiming that it has determined the US food supply is “safe,” neither the FDA nor EPA is doing any monitoring of US-grown products that would be able to support such a reassuring statement. This is grossly unscientific and irresponsible. See claims made to the Wall Street Journal http://online.wsj.com/article/SB1000142405274870380630457624497318701300...

We should be careful to make sure we’re looking at safety standards that the promulgating agencies will stand behind – AS safety standards."
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Keeping in mind that the EPA's Maximum Contaminant Level is 3.0 pCi/l, for all gamma emitters (I131, Cs134, Cs137, etc.), combined. McMahon used chargirl's research to launch an article questioning the reasons for the discrepancy between the EPA and FDA standards.

In response to McMahon's article, Siobhan DeLancey of FDA Office of Public Affairs, issued the following explanatory statement on 4/19/2011:

"The EPA MCLs are based on consumption of water every day for a period of 70 years under “normal” circumstances where little to no radioactivity is expected. The FDA DILs are conceived for emergency conditions only and provide a level of contamination where protective actions should be considered to avert further dose from accidental (or terrorist) contamination of food. This averted dose is referred to as the PAG or Protective Action Guide and for food is defined as 500 mrem (5 mSv) whole body (CEDE) or 5 rem (50 mSv) to a single organ (CDE). It is not intended, under the FDA paradigm, that an individual would continually consume contaminated food for a full year. However, for risk estimation purposes only, we have determined that, if someone were to consume contaminated food for a year, he/she would receive a dose estimated at 500 mrem (5 mSv) committed effective dose equivalent (CEDE), which corresponds to an excess risk of cancer mortality of approximately 1 in 4400 above the baseline of 1 in 5 for all people before any excess radiation exposure.

The terminology “mortality tolerance” is not used in practice and should not be used to imply that FDA is willing to allow consumption of radioactive food based on an “acceptable” level of mortality in the population. Risk coefficients (one in a million, two in ten thousand) are statistically based population estimates of risk. As such they cannot be used to predict individual risk and there is likely to be variation around those numbers. Thus we cannot say precisely that “one in a million people will die of cancer from drinking water at the EPA MCL” or that “two in ten thousand people will die of cancer from consuming food at the level of an FDA DIL.” These are estimates only and apply to populations as a whole. Our protective action guides and derived intervention levels are designed to avoid excessive dose and limit the risk to individuals from contaminated food. Further, our values have such a degree of conservatism that even if one were to consume food at the DIL, it is not conceivable that he/she would actually receive the PAG of 500 mrem/5 mSv. FDA would implement and recommend protective actions/interdiction long before anyone received a significant dose."
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So... your choice: take comfort in the fact that milk detections, and tuna detections and... (fill in the blank) continue to come in well-below the FDA's DIL... or understand that DIL for what it is, a compromise between industry (dairy, fisheries, import, etc.), and some modicum of consumer safety in the event of a radiological event.

Lastly, the Japanese government was the brunt of international scorn last year for increasing the acceptable radioactive cesium levels in food to 500 bq/kg, as an emergency standard. Japan has recently reduced the allowed contamination levels to 100 bq/kg.

US FDA DIL = 1200 bq/kg vs. Japanese maximum allowed contamination level = 100 bq/kg.

MM