Child Health Risk Analysis

The federal government formally adopted risk assessment in 1983 by publishing Risk Assessment in the Federal Government followed by the use of cost-benefit analysis with President Carter’s executive order in 1978.EO 12044). Despite their long-term use, there are hints that at least two federal agencies, the FDA and EPA, may be making public health decisions without using these tests.

The FDA in its plan called Closer to zeroresponds to the fact “what Americans want zero toxic elements in the foods their babies and young children eat. Recognizing that it’s impossible to reach zero for lead, arsenic, cadmium and mercury, the FDA insists that close to zero impact as far as possible.

Meanwhile, the EPA uses an extremely conservative safety analysis for four PFAS synthetic chemicals used ina wide range of industries since the 1940s“. PFAS health recommendations that are not enforceable and are not a regulatory decision (for now) is based on a decision management tool called “security analysis”. Safety assessments were developed by the FDA for pre-approval of chemicals before they could be sold as food additives (1958), around the same time that the World Health Organization accepted them for pre-approval of pesticides (1954).

Unlike a risk assessment, a safety analysis starts by finding the lowest possible exposure level that either causes very little or no harm, and then divides by “uncertainty factors” to find an exposure level that is a hundred or a thousand times below, where there is no “noticeable risk to human health”. Uncertainty factors are partly scientific, but some of them are actually arbitrary. The resulting risk level (as opposed to the actual risk assessment) for one of the PFAS (PFOA) chemicals was reported as four parts per quadrillionwhich is comparable to one drop of water in 20 000 Olympic size pools.

Both approaching zero and using a conservative safety level analysis are risk management decisions. Both ignore cost-benefit analysis.

This reaches a fairly safe level for PFAS chemicals and FDA chemicals in food, so we can ask the question: is there anything wrong with this, especially for children?

Many risk analysts might answer, “Perhaps.” That’s why.

Risk assessment and cost-benefit analysis can be valuable aids in making rational decisions about health hazards. With regard to chemicals management, these two analyzes answer the questions: 1) What is the risk at different levels of exposure to these chemicals? and 2) how much would it cost to reduce exposure to these chemicals, i.e. risk reduction?

Actual risk assessments answer the question, “What is the risk at a certain level of exposure?” Neither the FDA Closer to Zero report nor the EPA’s PFAS safety analysis provide an answer to this question.

A true risk assessment can show that any of these chemicals has a “threshold”, a level below which harm is unlikely to occur. EPA does list rapids for other chemicals, including pollutants subject to the Clean Air Act, which also includes risks to children. The FDA lists thresholds for package chemical substances, allergens and others connections.

There may also be hormetic (beneficial) effects at levels below the threshold of some compounds (e.g., methylmercury, cadmium as well as PFAS).

The second question relates to costs and benefits: how much will it cost to reduce the risks associated with these chemicals? Because nearly two-thirds of the US population drink water with some level of PFAS, in only one county, Orange County, California, the cost of the infrastructure needed to reduce PFAS levels was found to be “at least $1 billion.”

This brings us to the “better safe than sorry” standard, which even for children’s risks may not be true. The economist defines cost as “opportunity cost”, that is, the lost opportunity to spend those resources elsewhere. Where could billions or trillions of dollars be spent to reduce risks for children? The same applies to the cost of zeroing the risk of certain chemicals. If there is no risk, i.e., the risk is below the threshold of harm, then there is no benefit, and additional funds to reduce the risk are better spent elsewhere.

Some possible costs include buying more food fusion for kids or checking that the imported formula Safely. Another possibility is to help children avoid obesity and diabetes, problems that have been on the rise in recent years. By the time children reach the age of 6 to 11, one of five are obese. Maybe like the CDC reportsresources must be used to deal with unintentional injury or assault, which is the leading cause of death for young children.

In fact, given that there may be little or no benefit to children from reducing exposure to any of the chemicals approved by the Food and Drug Administration or the Environmental Protection Agency, we would probably be better off to deal with more serious problems for children.

Richard Williams

Richard Williams

Richard Williams is the author of the recently published Food Fix, FDA Insider Unravels Myths and Solutions.

He has written articles on regulation, food safety and nutrition, economic analysis and risk analysis.

Dr. Williams currently serves on two boards: the Institute for the Advancement of Food and Nutrition Sciences and is chairman of the Center for Truth in Science. He previously served on the Scientific Advisory Board of the Environmental Protection Agency.

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