Comments on carcinogenic solvents

The Center for Science in the Public Interest is writing to express strong support for two petitions filed by Environmental Defense Fund, et al. One requests that FDA amend the food additive regulations to remove approvals for four solvents: benzene, ethylene dichloride, methylene chloride, and trichloroethylene (TCE). The other requests that FDA amend the color additive regulations to remove approvals for the three of these four solvents appearing in the color additive regulations: ethylene dichloride, methylene chloride, and TCE.

View Comments

Under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, no food or color additive shall be considered safe, “if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” In 2018, FDA recognized its obligations under the Delaney Clause in its decision to grant a petition to withdraw its approval of seven carcinogenic flavors from the food additive regulations because they were shown to cause cancer in animal studies. The carcinogenic potential of all four solvents subject to these petitions is recognized by US and international authorities. Benzene and TCE are each classified as “known to be a human carcinogen” and ethylene dichloride and methylene chloride are each classified as “reasonably anticipated to be a human carcinogen” in the Report on Carcinogens published by the United States National Toxicology Program. The United States Environmental Protection Agency classifies benzene as a “known human carcinogen,” TCE as “carcinogenic to humans,” ethylene dichloride as a “probable human carcinogen,” methylene chloride as “likely to be carcinogenic to humans.” The World Health Organization’s International Agency for Research on Cancer classifies benzene and TCE as “carcinogenic to humans,” methylene chloride as “probably carcinogenic to humans,” and ethylene chloride as “possibly carcinogenic to humans.” FDA itself has acknowledged the carcinogenicity of benzene, TCE, and methylene chloride. FDA has stated that, “Benzene is a known human carcinogen that causes leukemia and other blood disorders” in an alert to drug manufacturers. Based on government-sponsored cancer studies in animals, FDA proposed to prohibit TCE in food in 1977. In 1989, FDA prohibited use of methylene chloride in cosmetic products due to cancer risk. FDA assessed the risk associated with the use of methylene chloride to decaffeinate coffee in 1985, and permitted this use despite acknowledging the cancer hazard because the agency determined the risk to be minimal, citing the de minimis doctrine. However, in 1987 in Public Citizen v. Young, the Court of Appeals for the D.C. Circuit held that Congress barred the FDA from employing a de minimis exception to the Delaney Clause, and FDA acknowledged this in 2018 in the context of other chemicals violating the Delaney Clause, stating: The Delaney Clause limits FDA’s discretion to determine the safety of food additives, in that it prevents FDA from finding a food additive to be safe if it has been found to induce cancer when ingested by humans or animals, regardless of the probability, or risk, of cancer associated with exposure to the additive or of the extent to which the experimental conditions of the animal study or the carcinogenic mode of action provide insight into the health effects of human consumption and use of the additive in question. In Public Citizen v. Young, the DC Circuit Court of Appeals held that Congress intended for the Delaney Clause to be ‘‘extraordinarily rigid,’’ to protect the public from cancer-causing substances without exception, rejecting FDA’s argument that a particular color additive, which was subject to a similarly worded Delaney Clause for color additives, should be approved because it did not pose more than a de minimis cancer risk. Thus, following this 1987 ruling, FDA should have revisited its 1985 methylene chloride decision and prohibited the use of methylene chloride to decaffeinate coffee. As such, the ban requested by Environmental Defense Fund et al. is long overdue and required by law. The cancer risks resulting from the use of these solvents in food may be small, but they are completely unnecessary, as there are safe alternatives that can be used. We urge FDA to act swiftly to grant these petitions and remove approvals for all uses of these solvents in food. Thank you for considering these comments.