Citizen petition requesting that FDA remove its prior sanction of five ortho-phthalates and ban eight ortho-phthalates

A coalition of environmental and health organizations petitioned the FDA to remove prior sanctions for five ortho-phthalates and ban eight others, arguing that these substances are pharmacologically related and pose cumulative health risks. The petitioners assert that current dietary exposure for women and children exceeds a proposed safety tolerance of 3 μg/kg bw/day, particularly for DEHP, DINP, and DIDP. They argue that the FDA's existing approvals are based on outdated data and that the agency has failed to conduct necessary post-market evaluations since 2008.

• The petitioners argue that 30 ortho-phthalates should be treated as a single chemical class because they share a common functional group (diesters of 1,2-dicarboxy-benzene) and similar metabolic pathways.
• The petition proposes a class-wide Acceptable Daily Intake (ADI) of 3 μg/kg bw/day, based on the lowest numerical tolerance of the most studied member, Di(2-ethylhexyl) phthalate (DEHP).
• Biomonitoring data indicates that average dietary exposures for women to diisononyl phthalate (4.8 μg/kg bw/day) and diisodecyl phthalate (3.2 μg/kg bw/day) already exceed the proposed 3 μg/kg bw/day tolerance.
• The petitioners identify a significant data gap, noting that 57% of the 30 ortho-phthalates have not been studied for reproductive, developmental, or endocrine toxicity.
• The petition requests a permanent ban on eight specific ortho-phthalates: Diisobutyl phthalate, Di-n-butyl phthalate, Butyl benzyl phthalate, Dicyclohexyl phthalate, Di-n-hexyl phthalate, Diisooctyl phthalate, Di(2-ethylhexyl) phthalate, and Diisononyl phthalate.
• The petitioners claim the FDA has failed to release results from a Phthalate Task Group formed in 2008 to conduct post-market evaluations of approved ortho-phthalate food additives.
• Evidence suggests that ortho-phthalates migrate into food not only from final packaging but also from raw material packaging and food handling equipment.
• The petition highlights that infants are particularly vulnerable, with some studies showing DEHP intake from baby food at 4.2 μg/kg bw/day, exceeding the proposed class tolerance.

APA

Earthjustice (2016). Citizen petition requesting that FDA remove its prior sanction of five ortho-phthalates and ban eight ortho-phthalates. https://earthjustice.org/wp-content/uploads/phthalates_petition_2016.pdf

Chicago

Earthjustice. Citizen petition requesting that FDA remove its prior sanction of five ortho-phthalates and ban eight ortho-phthalates. 2016. https://earthjustice.org/wp-content/uploads/phthalates_petition_2016.pdf.

Wikipedia

{{cite press release |author=Earthjustice |title=Citizen petition requesting that FDA remove its prior sanction of five ortho-phthalates and ban eight ortho-phthalates |date=19 April 2016 |url=https://earthjustice.org/wp-content/uploads/phthalates_petition_2016.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}

BibTeX

@misc{earthjustice2016citizen, author = {{Earthjustice}}, title = {{Citizen petition requesting that FDA remove its prior sanction of five ortho-phthalates and ban eight ortho-phthalates}}, publisher = {Earthjustice}, year = {2016}, month = apr, url = {https://earthjustice.org/wp-content/uploads/phthalates_petition_2016.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }