The Toxic Substance Control Act (TSCA) was recently on the list for my MPH Environmental Health as “ensuring a safe environment in the U.S.” In actuality, it has done the reverse, creating an illusion of protection where no protection really exists. Under TSCA, only six substances have ever been banned among the myriad carcinogens, neurotoxins, and endocrine disruptors known to contaminate every human being in the United States, including newborn babies. Of those six, one, asbestos, had that ban overturned in court. That is how hard it is to protect ordinary citizens against toxic chemicals under this law. Given the levels of pollution in every body in the U.S., it can be said with confidence that this Act is a complete regulatory failure. How much worse could it be? One might read that as a rhetorical question, but as I write, a new bill, The Chemicals in Commerce Act, is being shopped around the House of Representatives. This terrible piece of legislation, backed by chemical industry lobbyists, would actually be worse than the current law! Thousands of new chemicals would be rubber-stamped as “safe” without any testing at all. The USEPA requirements for registration of pesticides may seem stringent: “Potential registrants must generate scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide” (USEPA, 2013). But most of the data is generated using a single substance in animals, an experimental design that is not able to model chronic health hazards accurately. In addition, animal studies are not a perfect model for human systems, which can be much more complex, and keep in mind, humans live much longer and can therefore bio-accumulate greater amounts of chemical exposures from various sources. The elaborate review standards actually forbid the EPA from reviewing epidemiological data, which is the much stronger mode for connecting exposures to disease. Not long ago, I spoke with Shelia Zahm, one of the National Cancer Institute scientists most responsible for the epidemiological research on pesticide exposures and childhood cancer, which have been abundantly linked by numerous studies. She pointed out many of the well-known problems with the regulations as they exist today, in material that has only been previously published on my blog.
This is what she would do if she had control of the regulatory agencies:
I think the most important thing is to change the burden of proof. Things should be proven to be safe before they are introduced rather than waiting to find they are harmful after the horse is out of the barn. There were so many chemicals that were grandfathered in when toxic substances were regulated in this country, and they’ve never gone back and researched the chemicals. We should also change access to information. For example, pesticide companies only have to reveal “active” ingredients, meaning those with pesticidal activity. Many of the other ingredients in pesticide formulations are not biologically inert, but they are not considered a pesticide, so they don’t have to be listed. That information is protected, proprietary. The information needs to be public for research on safety.
Regulators also need to increase consideration of exposures across the lifetime, not just consider exposure as adults. We need to know what happens if one is exposed prenatally, in childhood, at menarche, before the first birth, during pregnancy, etc., across the lifespan. We should conduct animal and in vitro testing taking into account populations that have special susceptibility, like children and those with impaired immune systems. Regulators need to think of the exposures and susceptibilities of the most vulnerable populations, not just the “average adult” in testing.
Historically, most carcinogen testing was designed to identify direct carcinogens. What if the substance just changes immune function, and that changes the ability to fight disease? Will the testing regimens detect those changes? In general, the regulatory system has been designed using data from animal studies. The agencies don’t really know what to do with epidemiological studies. Often the exposure assessment may not be detailed enough to use in the risk assessment models the agencies use, and there is often concern about confounding or other bias. If the human studies are positive, but animal studies are not, usually nothing happens.
The US regulatory landscape also needs more post-marketing monitoring particularly for drugs but other newly introduced compounds as well. Without well-designed follow-up studies, we can miss detecting modest increases in common outcomes. An “alert clinician” may notice an extremely unusual outcome caused by an exposure, but cannot detect a small increase in a common disease. (Zahm, 2014).
If only scientists like this, who actually seem to care about the impact of chemicals on human health, had control of our regulatory system, so many people would not have died miserable deaths from cancer or suffered from life-altering conditions like autism, ADHD, diabetes, Parkinson’s Disease, and auto-immune illnesses of all kinds.
Much of the pesticide safety research that is done is sponsored by the companies seeking registration and is not published in peer-reviewed journals. Most chemicals were grandfathered in under TSCA (Toxic Substance Control Act), and once registration is granted, chemicals are rarely re-reviewed, even given substantial evidence of harm. According to the Environmental Defense Fund, TSCA
- has failed to deliver the information needed to identify unsafe — as well as safer — chemicals,
- forbids the federal government from sharing much of the limited information it does obtain,
- imposes a nearly impossible burden on government to prove actual harm in order to control or replace a dangerous chemical and
- thereby perpetuates the chemicals industry's failure to innovate toward inherently safer chemical and product design. (EDF, 2014).
In April 2013, Senators Frank Lautenberg and Kristen Gillibrand introduced a bill, the Safe Chemicals Act, that would update this antiquated law and provide a greater measure of safety for every U.S. citizen. In May, 2013, Lautenberg and David Vitter introduced an updated bill called the Chemical Safety Improvement Act with partisan support. The comment period for this bill has passed, but many other rules governing pesticides and other toxic chemicals are on the docket. For instance, there were several petitions by pesticide companies to increase the allowances for pesticide residues on certain foods, as well as agricultural products fed to food livestock, like alfalfa, for instance. I commented on all of these petitions with the following paragraphs:
Dear EPA Scientists, I hope you will reconsider before loosening tolerances on any food items, imported or domestic, or agricultural products destined for food animals. You list those concerned as being involved in crop or animal production, food or pesticide manufacturing, but you seem to forget the most important party concerned: the American citizens you are supposed to be protecting. I refer to a small assemblage of Pesticide Petitions with the following docket numbers: EPA-HQ-OPP-2013-0662-0002, EPA-HQ-OPP-2014-0114-0002, EPA-HQ-OPP-2014-0153-0002, EPA-HQ-OPP-2014-0230-0001, EPA-HQ-OPP-2013-0644-0002, EPA-HQ-OPP-2014-0225-0002, EPA-HQ-OPP-2014-0297-0001, EPA-HQ-OPP-2013-0255-0011, EPA-HQ-OPP-2014-0161-0001, EPA-HQ-OPP-2014-0210-0001, EPA-HQ-OPP-2014-0238-0001, and EPA-HQ-OPP-2014-0207-0001. These petitions address many different pesticides (a term that includes insecticides, herbicides, fungicides, etc.) and many different products. I am making an argument that regulations of these dangerous chemicals – all of them – should be significantly tightened. It is an issue of environmental justice that our youngest citizens – our children – are disproportionately exposed to health risks.
The President’s Cancer Panel (PCP) Report of 2010 and the American Academy of Pediatrics (AAP) in 2013 assign much of the blame for rising cancer rates in children to virtually unregulated pesticide exposures. The CDC Biomonitoring Project shows that every American is contaminated with hundreds of toxic chemicals, even before birth (CDC, 2005). The very conservative AAP has this to say about the data:
The past decade has seen an expansion of the epidemiologic evidence base supporting adverse effects after acute and chronic pesticide exposure in children. This includes increasingly sophisticated studies addressing combined exposures and genetic susceptibility…. The evidence base is most robust for associations to pediatric cancer and adverse neurodevelopment. Multiple case-control studies and evidence reviews support a role for insecticides in risk of brain tumors and acute lymphocytic leukemia. (AAP, 2013).
It would be unconscionable to continue ignoring the epidemiologic data, which is superior to animal studies in assessing harm.
The President’s Cancer Panel is even more explicit. The President’s Cancer Panel, appointed by President Bush, whose 2008-2009 Annual Report reviewed 454 sources and found that many cancers, perhaps most, could be prevented by cleaning up the environment in just a few high-impact ways. In the letter to the President that precedes the report, they could scarcely have stated the alarm their findings raised more strongly:
The Panel was particularly concerned to find that the true burden of environmentally induced cancer has been grossly underestimated. With nearly 80,000 chemicals on the market in the United States, many of which are used by millions of Americans in their daily lives and are un- or understudied and largely unregulated, exposure to potential environmental carcinogens is widespread…. The grievous harm from this group of carcinogens has not been addressed adequately by the National Cancer Program. The American people – even before they are born – are bombarded continually with myriad combinations of these dangerous exposures. The Panel urges you most strongly to use the power of your office to remove the carcinogens and other toxins from our food, water, and air that needlessly increase health care costs, cripple our Nation’s productivity, and devastate American lives.
The lack of regulation has devastated our lives. Our eight-year-old daughter Katherine died in 2002 of leukemia we have every reason to believe was caused by her unwitting exposure to chlorpyrifos. We thought she was protected when chlorpyrifos was banned for residential use in 2001, but there was a loophole for mosquito spraying, which we did not realize had occurred from her infancy onwards. There is always a loophole, and these pesticide petitions are some of them. We know your hands are partly tied by the weakness of TSCA. The Safe Chemicals Act, sponsored by Frank Lautenberg, would be a step in the right direction; but in the meantime, you at the EPA are all that protects our children, and you have largely failed to do so, not just by our accounting, but according to the PCP and AAP. You must do what you can where you can. Having an Environmental Protection Agency gives people the illusion that they are protected from environmental exposures, when nothing could be further from the truth. Registration implies to most people that the chemicals in question have been thoroughly researched and have negligible human health risks. That is simply not the case.
Jean-Marie Kauth, PhD
American Academy of Pediatrics (AAP). (2012). Policy statement: Pesticide exposure in children. Pediatrics 130 (6):e1757-e1763. Retrieved from http://pediatrics.aappublications.org/content/130/6/e1757.full
Centers for Disease Control and Prevention (CDC). (2005). Fourth National Report on Human Exposure to Environmental Chemicals. Atlanta (GA). Retrieved from http://www.cdc.gov/exposurereport/
Infante-Rivard, C., Weichenthal, S. (2007). Pesticides and childhood cancer: An update of Zahm and Ward’s 1998 review. J Toxicol Environ Health, Part B 10:81-99.
President’s Cancer Panel (PCP). (2010). Reducing Environmental Cancer Risk: What We Can Do Now. U.S. Department of Health and Human Services. Retrieved from http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp08-09rpt/PCP_Report_08-09_508.pdf
It’s amazing how much regulatory activity occurs, without it being effective. What has happened, I think, is that chemical companies lobby and bully regulators and politicians until the laws are basically useless, but those politicians and regulators are still gainfully employed in making those laws, pushing paper (figurative or literal) around, fidgeting with half-measures and token, though detailed, procedures. No one seems to care at all about the many people killed by our loose chemical regulatory environment, and in fact, perhaps they fool themselves into thinking that they are doing something significant. Results say otherwise.
Even if we are pessimistic about our ability to protect our children and ourselves and make a difference, however, we have an obligation to cry out against systematic poisoning by chemical companies and the agricultural industry, sanctioned by our government, lest we be complicit in our own ill health and premature deaths.
American Academy of Pediatrics (AAP). 2012. Policy statement: Pesticide exposure in children. Pediatrics 130(6):e1757-e1763.Environmental Defense Fund (EDF). 2014. Chemicals policy reform. Retrieved from http://www.edf.org/health/policy/chemicals-policy-reform
U.S. EPA. (2013). Test guidelines for data requirements. USEPA. Retrieved from http://www.epa.gov/pesticides/science/guidelines.htm
Zahm, S.H. (2014). Personal Communication.