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Poisoned Legacy

Ten Years Later, Chemical Safety and Justice for DuPont’s Teflon Victims Remain Elusive

The Problem With Phase-outs

May 1, 2015

Poisoned Legacy: The Problem With Phase-outs

In 2006, more than three years after EPA first announced its “emergency” review of PFOA, DuPont and other makers or users of PFOA in the U.S. – Arkema, Asahi, BASF, Clariant, Daikin, Dyneon (a division of 3M) and Solvay Solexis – agreed to participate in the PFOA Stewardship Program. Its stated goals reflect the slow, incremental and unenforceable process that typically follows announcement of a “voluntary” chemical phase-out. (EPA 2015B):

  • To achieve, by no later than 2010, a 95 percent reduction – measured from a year 2000 baseline – in emissions of PFOA, of precursor chemicals that can break down to PFO, and of related “higher homologue” chemicals, as well as in the levels of these chemicals in manufactured products.
  • To work toward eliminating these chemicals from emissions and products entirely by 2015.

EPA launched the program in 2006, but the Food and Drug Administration, which regulates chemicals in food and food packaging, did not request additional safety data from DuPont until 2008 and from BASF until 2010. DuPont, BASF and Clariant all disagreed with FDA that more testing was needed, but they agreed to stop distribution of PFOA at the end of 2011. (FDA 2012A, FDA 2012B, FDA 2012C)

The painfully slow process of reducing the public’s exposures to PFCs reflects one of the biggest flaws of the 1976 Toxic Substances Control Act – that the EPA assesses health hazards chemical by chemical, rather than as a family. Because the act places the burden on EPA to prove that a chemical is a hazard – rather than requiring the manufacturer to prove that it’s safe – the law effectively prevents the EPA from banning chemicals. Instead, the agency relies on what are called Significant New Use rules. In the absence of clear authority to ban chemicals, these rules give the agency a way to limit new uses of chemicals that may present a significant risk. EPA does not have the regulatory authority to halt ongoing uses other than negotiating a phase-out, largely on the manufacturer’s terms.

The Significant New Use rules require a company to notify EPA when it decides to manufacture for new uses or in new ways a chemical known to present a significant risk. The agency may order the company not to market the chemical or to conduct additional safety testing. Although EPA has stepped up its use of Significant New Use rules in recent years, they are still issued infrequently. It takes an average of three-to-five years for the agency to marshal the information necessary to order more testing and an additional two or more years for a company to comply. During that time the chemical may be produced and marketed without restriction. (GAO 2013) By not requiring that companies prove the safety of all chemicals before they go on the market – the precautionary principle underlying chemical regulation in the European Union, Australia and Japan – this system fails to protect Americans’ health.

After 3M disclosed to EPA what it knew about the hazards of PFOS in 2000 and agreed to a phase-out, the agency promulgated Significant New Use Rules for 88 PFOS-related compounds. (EPA 2002A, EPA 2002B) In 2007, it adopted an additional rule covering another 183 PFOS-related chemicals. (EPA 2007) However, EPA exempted so-called low-volume, low-exposure uses for which there is supposedly no viable alternative.

In January 2015, the final year of the PFOA Stewardship Program, EPA proposed an additional Significant New Use Rule for C8/PFOA and 25 other long-chain PFCs. (EPA 2015a) The rule also covers other long-chain fluorinated chemicals that could be synthesized and commercially viable.

By the end of 2015 EPA will have removed or restricted approximately 300 distinct PFCs from the market. But the process is masked in secrecy. The names of some of the chemicals subject to the 2007 rule on PFOS chemicals are kept secret as confidential business information, even though they are scheduled for phase-out. (EPA 2015B) Under the 2015 rule, the production volume and imported quantities are claimed as trade secrets for almost all the covered chemicals. This is hardly a surprise. According to a report by the Government Accountability Office, 95 percent of the information EPA receives on new chemicals contains confidentiality claims. (GAO 2013) The secrecy about what chemicals are being produced and in what volumes greatly hinders efforts by independent scientists to monitor their levels in the environment and in people and to study the possible health hazards. (EPA 2014, EPA 2015)

Enforcement is Weak, Ineffective

Section 8(e) of the Toxic Substances Control Act requires U.S. chemical manufacturers, importers, processors and distributors to notify EPA within 30 days of learning that a chemical may pose a “substantial risk of injury to health or the environment.” (EPA 2015) But the DuPont case shows that even the most serious violations do not trigger penalties sufficient to ensure compliance.

DuPont’s failure to submit studies on PFOA from 1981 to 2005 led to a $16.5 million fine, “the largest civil administrative penalty EPA has ever obtained under any federal environmental statute.” (EPA 2005) But EPA could have imposed a fine of up to $313 million – still $20 million less than the company’s third-quarter profit the previous year. (EWG 2004) The settlement gave DuPont a decade to continue using PFOA, a chemical that generated revenue of $1 billion a year. (Haber 2005) The Justice Department considered filing criminal charges against DuPont but decided in 2007 not to pursue the case. (Greenspan 2007)

Although company submissions under Section 8(e) must be made public, critical details are often kept secret as “confidential business information.” EWG reviewed more than 100 Section 8(e) submissions for fluorinated chemicals from January 2007 to March 2015. More than 85 percent did not disclose the name of the chemical involved and more than 55 percent did not disclose the name of the company. This secrecy makes it impossible for the public, state regulators or independent scientists to assess the chemical’s use and how people are exposed.

In light of the health effects reported in the studies, this lack of transparency is extremely disturbing. In studies in which the chemical’s name was withheld, reported health effects of exposure included death; maternal and developmental toxicity; degeneration and necrosis of the kidneys; chromosome aberrations; changes to the weight of the heart, kidney, liver, thymus, spleen, prostate, ovaries and adrenal glands; lethargy; and irregular breathing. This is a sampling of the submissions in which vital information was not disclosed:

  • One submission detailed how rats exposed to an unknown fluorinated chemical experienced obstructed labor, decreased fertility, skeletal abnormalities in offspring and lower maternal and offspring viability during lactation. The August 15, 2007, submission did not identify the manufacturer. (Read the studies: PDF 1 PDF 2 .)
  • In another reproductive study of a chemical identified only as a fluorinated aliphatic alcohol, exposed rats died, had lower body weight, experienced nursing difficulties and discolored teeth, reduced uterine weight, height, increased pup morality during lactation from dehydration, failure to nurse and nest and being cold to the touch. The study was submitted by an unidentified manufacturer on July 18, 2008. (Read the study: PDF.)
  • In May 2011, 3M submitted a study of a fluorinated derivative that in test animals caused labored breathing, sluggish movement, dark eye color, delayed responses, jerky movement, extreme lung sounds and death. (Read the study: PDF.)