Most people will find this topic uninteresting. But it is a big deal, and will be one of the biggest changes in regulatory politics over the next decade.
In the US, regulatory authority over chemicals that may affect human well-being is spread over different agencies. The FDA has responsibility for most food, but food producers use a vast array of substances that are regulated by other agencies. USDA sets standards for most chemicals used in meats. Standards for water, pesticides, fungicides, and industrial chemicals are set by the EPA. Since the Toxic Substances Control Act was passed in 1976, which is when we started keeping track, over 80,000 new industrial chemicals were introduced into our environment. We have thorough testing results on only a few of them.
This matters because these chemicals get into us, and affect our health. When people take the trouble to get tested for a wide range of industrial chemicals they may be exposed to at work, at home, or through unknown exposure, they find their bodies contain a soup of contaminants.[1]
The chemicals that are allowed in our food are also problematic. Consider the ambiguity between the definition of an industrial chemical and a component of food. What qualifies as a natural flavor, for example? Can both be “natural”? Is a combination of different chemicals, however produced, not found in nature but tasting just like something in nature, a natural flavor? Is it a natural flavor because it is labeled as such, and tastes like lemon, even though it has no lemons in it and is mass produced in China (as is most of what you think is lemon flavored)?[2]
Many chemicals not intended for the food chain find their way into it, via water, air, or surprising means of transmissions. Things sprayed on plants may, from the perspective of one who eats those plants, may actually be in them. In a now infamous case, the bits of beef carcasses that used to be waste processed into pet food are now treated with NH3—which perhaps sounds better than ‘ammonia’—and is added to ground beef The ammonia was defined by USDA as a treatment, not an additive.[3]
Of the tens of thousands of new chemicals introduced into the food chain by these various means, almost none of them are actually tested for safety. Among the suspected neurotoxins, for example, only three out of more than two hundred have been adequately investigated, and the suspicions were confirmed.[4] In other words, 100% of the suspected neurotoxins that have been adequately tested have confirmed the fears. Yet we do not aggressively investigate the remaining suspects.[5] Once we do start testing, the work to be done in setting standards for chemicals testing may qualify for one of the labors of Hercules. For example, there are no required ethical standards, or oversight, for testing pesticides on human subjects.[6]
The testing of products for human consumption that is done is subject to error, of course, but sometimes the errors lean so far in one direction that one could easily conclude the entire system suffers from a bias against public health.[7]
The EU empowered its European Chemicals Agency (ECHA) to administer its new REACH standards for chemicals (Registration, Evaluation, Authorisation and Restriction of Chemical substances). The legislation passed in 2007 and the active implementation begins in 2010. Chemical companies will be obligated to conduct extensive safety tests on new chemicals and for those currently in use.
While the US approach to chemicals is quite different, it and the EU countries are affected by new developments in testing technologies that promise to produce a dramatic increase of data and useful test results. For example, to test the effects of chemicals on humans has required extensive and time-consuming animal tests. Cost pressures contributed to the development of in vitro cell tests. Yet individual cells have so many targets for the many chemicals recently introduced into our environment. It would help sort through the mess if scientists develop a limited number of genes that can signal if a cell would be harmed by a wide range of chemicals. It would help if more detailed tests of blood components could quickly identify if individuals were responding in particular ways to chemical exposures. The new types of tests could essentially be automated, which means tests of individual chemicals would become much cheaper. Such tests are being evaluated right now.[8]
Between the new regulatory requirements and the new testing techniques, regulators expect an avalanche of data that they are presently unprepared to organize and use. A recent report from the FDA Science Board’s Subcommittee on Information Technology found that, with the possible exception of new drug review, the agency is not now prepared to deal with today’s volume of information, and that rather dramatic upgrades of capabilities are in order.[9] The tone of the report was that since this is a minimal requirement for the FDA to do its job, of course lawmakers will provide the needed resources. This report was done two years after a major FDA Science Board report included information technology as a critical inadequacy, and that without an urgent fix the agency would not be able to do its job.[10]
Both the European REACH and US approaches rely heavily on private companies to finance and report the tests of their chemicals. There are, of course, perverse incentives at work here. Companies that stand to make a lot of money upon getting a ‘safe for consumption’ label on their product will be doing the research. To address this, rules for testing, and testing protocols, need to be clearly specified. Plus, the data need to be “harmonized,” meaning that everyone needs to use similar reporting codes so that we will be able to make fairly consistent decisions across chemicals.
In the US, such rules were voluntary in our recent past. Any attempt to do what must be done will be labeled as a dramatic increase in government power.
REACH is an attempt to make such rules compulsory in Europe, but the US is not yet ready to take this step. Companies in Europe have to demonstrate their new chemicals are safe, while in the US it is up to the EPA, chronically underfunded, to investigate and prove if a chemical is unsafe, and then pursue regulation in a way that is ‘least burdensome’ to reduce risk to acceptable levels.[11]
In both the European and US approaches the stakeholder model is used to write and to evaluate the rules for testing. This introduces some interesting issues into the regulation of chemicals. Complexities of the stakeholder model will be the subject of a subsequent entry.
[1] See Is It In Us? Toxic Trespass, Regulatory Failure & Opportunities for Action, The Commonweal Biomonitoring Resource Center and the Body Burden Working Group, 2007, available at http://cdn.publicinterestnetwork.org/assets/zC9kECTDtAMQl5kgCDFA4w/Is-it-in-US-Report.pdf. See also Bobbi Chase Wilding, et. al., Hazardous Chemicals In Health Care, Physicians for Social Responsibility, 2009, available at http://www.nursingworld.org/DocumentVault/OccupationalEnvironment/Hazardous-Chemicals-In-Health-Care.aspx.
[2] For an illuminating description of the natural flavor business, see Raffi Khatchadourian, Annals of Science, “The Taste Makers,” The New Yorker, November 23, 2009, p. 86+.
[3] See the last page of Reference Document: Anti-microbial Interventions for Beef, Center for Food Safety, Department of Animal Science, Texas A&M University, May 2009, available at http://haccpalliance.org/sub/Antimicrobial%20Interventions%20for%20Beef.pdf.
[4] See, for example, P. Grandjean, P.J. Landrigan, “ Developmental neurotoxicity of industrial chemicals,” Lancet Published Online November 8, 2006DOI:10.1016/S0140‐6736(06)69665‐7. 100% of suspected neurotoxins we have thoroughly investigated have turned out to be toxic, and programs are underway to control them. Yet besides the three investigations, hundreds more await analysis.
[5] This one example is repeated for many contaminants in our foods. One book that tracked down the leads on many chemicals is Robyn O’Brien,, with Rachel Kranz, The Unhealthy Truth: How Our Food Is Making Us Sick—and What We Can Do About It (NY: Broadway Books, 2009).
[6] See Christopher Oleskey, et.al., “Pesticide Testing in Humans: Ethics and Public Policy,” Environmental Health Perspectives, Volume 112, Number 8, June 2004, pp. 914-919.
[7] See, for example, Amir Miodovnik and Philip J. Landrigan, “The U.S. Food and Drug Administration Risk Assessment on Lead in Women’s and Children’s Vitamins Is Based on Outdated Assumptions,” Environmental Health Perspectives Volume 117, Number 7, July 2009, pp. 1021-2.
[8] For a quick summary of several dozen new approaches to chemical testing, see Toxicity Pathway-Based Risk Assessment: Preparing For Paradigm Change, program for a meeting at the National Academy of Science, Washington, DC, May 11-13, 2009.
[9] FDA, Science Board Subcommittee Review of Information Technology, August 2009, quite difficult to find on their website but available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/UCM182872.pdf.
[10] FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, Prepared for FDA Science Board, November 2007.
[11] General Accountability Office, Chemical Regulation: Comparison of U.S. and Recently Enacted European Union Approaches to Protect against the Risks of Toxic Chemicals, August 2007, available at www.gao.gov/cgi-bin/getrpt?GAO-07-825.
