The system through which US government agencies protect the public’s health, safety, and environment is being severely challenged. It faces concerted efforts to weaken the laws and regulations that require corporations to limit air and water pollution, clean up land or drinking water they have contaminated, market safe products to consumers, and eliminate workplace hazards. At the same time, there is an exodus of dedicated and experienced civil servants who are frustrated with these new developments. Much effort will be needed to rebuild this system of vital protections.

The success of the US regulatory system in safeguarding the public’s health is so impressive that we often take it for granted. The work of the Food and Drug Administration (FDA) to protect us from adulterated food or drugs that are ineffective or unduly dangerous is the model for much of the world. Thanks to the Environmental Protection Agency’s strengthened requirements, our air and water have become dramatically cleaner than they were when the agency was established almost 50 years ago. The nation’s workers are far safer because of the efforts of the Occupational Safety and Health Administration, which has reduced both on-the-job injuries and exposures to known hazards such as asbestos and benzene.

These successes have never come easily. Issuing new regulations often takes many years and substantial time and resources because the rules and procedures that federal agencies must follow require extensive public input along with technical analyses quantifying the harm caused by the product or activity and the costs and benefits of the new protections. The agencies almost inevitably face strong opposition because it is the rare corporation that welcomes regulation of its product or activity, no matter how hazardous.

This reflexive opposition is not a new problem. Even following the notorious Triangle Shirtwaist Factory fire more than a century ago, when 146 workers died gruesome deaths—mostly young Italian and Jewish immigrant women—real estate interests opposed regulations requiring fire-suppressing sprinkler systems, and manufacturing companies campaigned against rules prohibiting children from working in dangerous jobs. More recently, automobile manufacturing firms opposed requirements to install seatbelts and air bags.

The list of public health protections opposed by industry is long, but contrary to the mercenary refrain “regulations kill jobs,” these and so many others have saved lives at costs far lower than the benefits they provide. Once new protections are enacted, firms generally come to realize that the new requirements are not as onerous as feared, and their business interests can be comfortably pursued while the public is better protected.

The basis of individual liberty is laws and regulations through which the government protects each person from harm by the actions of others.1 While individuals can reduce their personal carbon footprints, government action is necessary to significantly reduce greenhouse gas emissions driving climate breakdown. Similarly, as individuals, there is little we can do when faced with population-wide threats such as foodborne disease outbreaks, antibiotic resistance, water contaminated by toxic chemicals, or chemical factories catching fire and making the outdoor air too dangerous to breathe.

Currently, with an antiregulatory political regime in power, it has become much easier for polluters and manufacturers of dangerous products to succeed in stopping or rolling back public health protections. In the near future, we will need to rebuild this system. But rather than simply returning to our past approaches, with their many successes but also severe limitations, this is an opportunity to reimagine how our system could be made more effective.

The first step is to look at our historical failures, instances in which well-intentioned agencies were unable to overcome opposition to regulation. One illustrative example is how the Cosmetic, Toiletry, and Fragrance Association (CTFA), representing manufacturers of consumer talcum powder products, was able to convince the FDA not to regulate its products as carcinogens, although there was evidence that the products contained small amounts of asbestos, a substance known to cause cancer at even very low exposure levels.

In the case documented by Rosner et al. in this issue of AJPH (p. 969), the FDA proposed requiring that talc products be virtually asbestos-free but then retreated, yielding to the CTFA’s arguments that the methodology for measuring the asbestos content of talc would be burdensome to industry. The agency permitted the industry to develop its own less stringent detection methods. The industry was also able to change the definition of cosmetic talc from asbestos-free to a product whose asbestos content was “nondetected,” although the detectability of asbestos is determined by the methods used.

It is likely that the FDA yielded to the CTFA for the same constellation of reasons that many public health protection efforts fail. The underfunded agency, charged with overseeing the safety of products that account for more than 20 cents of every dollar spent by US consumers, had other pressing concerns and did not devote the staff or technical resources to exploring ways to improve asbestos-testing methods. The law authorizing FDA to regulate cosmetics was and remains weak, and the agency was likely hesitant to take on a protracted legal battle with a trade association backed by some of the nation’s largest corporations.

By 1977, the FDA had essentially accepted the CTFA’s assertions that their talc products were safe. There were not yet studies of cancer risk among talc consumers, and the FDA did not insist that the industry test the product further to determine its safety. With the coming of the Reagan administration in 1981, public health agencies became more responsive to corporate concerns and the FDA never revisited its decision, even as asbestos detection methods continually improved. In 1982, the first study linking consumer talc use with ovarian cancer was published.2

Now is the time for a national conversation about how to reimagine our system of public health protections to be more effective. One immediate need is adequate resources. The defense of the nation’s homeland security is generously funded, but defense of our public health and safety is not. Here are two of many examples: the Occupational Safety and Health Administration, the agency I ran during the administration of President Barack Obama, has enough inspectors to visit every workplace once every 165 years.3 It became clear in the investigation into the recent crashes of two Boeing 737 Max jets that the Federal Aviation Administration, lacking adequate resources and staffing and too deferential to the regulated industry, has increasingly delegated authority to certify the safety of airplanes to the planes’ manufacturers.4

Beyond additional funding, it is important to explore and implement programs and policies that discourage irresponsible corporate behavior. Voluntary guidelines and self-certification may be useful in advancing safety, but they have been widely embraced without adequate evaluation. Litigation, especially class action suits, can also drive corporations to act more responsibly. Rather than limit these suits (as recent Supreme Court decisions have done), perhaps they should be encouraged.

Finally, polluters and producers of dangerous products often employ mercenary scientists to manufacture uncertainty about the harms of their products to weaken regulation or defeat litigation.5 Needed are structures and policies that ensure the production and synthesis of scientific evidence by unconflicted scientists. But we cannot always wait for the evidence. Many of our public health laws place the burden on public health agencies to prove products or activities are dangerous before they can act to protect the public. In our system of criminal justice, people are innocent until proven guilty, but that presumption of innocence should not apply to chemicals and other products that might be reasonably predicted to be harmful. Waiting for proof of harm before taking action will too often permit harm to occur.

See also Morabia, p. 955; Rosner et al., p. 969; Samet, p. 976; Vineis, p. 978; Rodenberg, p. 980; and Singla et al., p. 982.

CONFLICTS OF INTEREST

I served as a fact witness in a lawsuit involving talc and ovarian cancer and received no financial compensation for my testimony.

References

1. Singer JW. No Freedom Without Regulation. New Haven, CT: Yale University Press; 2015. CrossrefGoogle Scholar
2. Cramer DW, Welch W, Scully R, Wojciechowski C. Ovarian cancer and talc: a case–control study. Cancer. 1982;15;50(2):372376. CrossrefGoogle Scholar
3. AFL-CIO. Death on the job. The toll of neglect. A national and state-by-state profile of worker safety and health in the United States. 28th ed. April 2019. Available at: https://aflcio.org/sites/default/files/2019-04/DOTJ2019nb.pdf. Accessed April 25, 2019. Google Scholar
4. Gates D. Flawed analysis, failed oversight: how Boeing, FAA certified the suspect 737 MAX flight control system. Seattle Times. March 17, 2019. Available at: https://www.seattletimes.com/business/boeing-aerospace/failed-certification-faa-missed-safety-issues-in-the-737-max-system-implicated-in-the-lion-air-crash. Accessed April 24, 2019. Google Scholar
5. Michaels D. Doubt Is Their Product. New York, NY: Oxford University Press; 2008. Google Scholar

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David Michaels, PhD, MPHDavid Michaels is with the Milken Institute School of Public Health, George Washington University, Washington, DC. He served as Assistant Secretary of Labor for the Occupational Safety and Health Administration from 2009 to 2017. “Reimagining Our System for Public Health Protection”, American Journal of Public Health 109, no. 7 (July 1, 2019): pp. 975-976.

https://doi.org/10.2105/AJPH.2019.305126

PMID: 31166749