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Court of Appeal:
Chemical May Be Listed as Hazardous Based on Tests on Rats Reported in a Single Study
By a MetNews Staff Writer
A state agency did not abuse its discretion in listing a chemical, widely used in coating food and drink containers, as one which causes reproductive toxicity although the decision was based on a study of the effect on rats rather than humans, and without considering the views of a panel of experts appointed by the governor who proclaimed the compound to be safe, the Third District Court of Appeal held yesterday.
The state Office of Environmental Health Hazard Assessment (“OEHHA”) decided to list Bisphenol A (“BPA”) as a chemical known by the state to cause reproductive toxicity. It acted under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986.
OEHHA relied on a 2008 monograph published by a unit of the National Toxicology Program, a multi-agency effort run by the U.S. Department of Health and Human Services. The monograph said:
“Although there is no direct evidence that exposure of people to [BPA] adversely affects reproduction or development, studies with laboratory rodents show that exposure to high dose levels of [BPA] during pregnancy and/or lactation can reduce survival, birth weight, and growth of offspring early in life, and delay the onset of puberty in males and females.”
Judgment Affirmed
Yesterday’s decision affirms a judgment by Sacramento Superior Court Judge Timothy M. Frawley in favor of ORHHA in an action brought by the American Chemistry Council (“ACC”), a trade association for chemical companies, seeking an injunction and writ relief blocking the listing of BPA as a health hazard.
Justice William J. Murray Jr. said that “OEHHA’s position as to biological plausibility is based on, among other things, the following presumption: chemicals that cause harm in experimental animals will also cause similar harm in humans in the absence of evidence to the contrary.”
That presumption, he declared, is valid, explaining:
“[F]or a chemical to be formally identified as causing cancer or reproductive toxicity, it need not be proven that the chemical causes cancer or reproductive toxicity in humans. Proposition 65 applies to those chemicals which authoritative bodies have already determined cause cancer or reproductive toxicity in humans or experimental animals.”
Experts’ Views
OEHHA apparently did not take into account the Occupational Safety and Health Administration’s view of the department’s own Developmental and Reproductive Toxicant Identification Committee (“DART-IC”), comprised of scientists with expertise in the field. They opined that BPA should not be contained in the list of “chemicals known to the state to cause cancer or reproductive toxicity” which, under Health & Safety Code §25249.8(a), the governor must publish “at least once per year.”
Murray wrote:
“If, under an applicable statute or regulation OEHHA were required to consider DART-IC’s determination, and if we concluded that OEHHA failed to do so, it is possible those circumstances would establish an abuse of discretion by OEHHA. However…, we find no such statutory or regulatory requirement, and, accordingly, no such abuse of discretion.”
BPA is not presently listed as a toxic chemical. It had been so listed; the Superior Court granted a preliminary injunction and it was de-listed; a judgment was entered denying a permanent injunction or other relief, but the Third District granted ACC’s petition for a writ of supersedeas.
The case is American Chemistry Council v. Office of Environmental Health Hazard Assessment (Natural Resources Defense Council), 2020 S.O.S. 4853.
FDA’s View
The federal Food and Drug Administration (“FDA”) does not view BPA—used in the making of plastics and resins used in food and drink containers such as water bottles—as hazardous, in its present applications. It said in a January 2010 report, updated June 27, 2018:
“FDA’s current perspective, based on its most recent safety assessment, is that BPA is safe at the current levels occurring in foods. Based on FDA’s ongoing safety review of scientific evidence, the available information continues to support the safety of BPA for the currently approved uses in food containers and packaging.”
The reports notes:
“•FDA has amended its regulations to no longer provide for the use of BPA-based polycarbonate resins in baby bottles and sippy cups. In July, 2012, FDA took this action in response to a food additive petition filed by the American Chemistry Council….The ACC petition demonstrated, from publicly available information and information collected from industry sources, that the use of polycarbonate resins in baby bottles and sippy cups had been abandoned.
“•FDA has amended its regulations to no longer provide for the use of BPA-based epoxy resins as coatings in packaging for infant formula. In July, 2013, FDA took this action in response to a food additive petition filed by Congressman Edward Markey of Massachusetts. This petition demonstrated, from publicly available information and information collected from industry sources, that the use of BPA-based epoxy resins as coatings in packaging for infant formula had been abandoned.”
Copyright 2020, Metropolitan News Company