EPA Grants Petition to Address PFAS Created by Plastic Fluorination

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On July 10, 2024, EPA granted a citizen petition from environmental groups encouraging EPA to take Toxic Substances Control Act (TSCA) section 6 action for three PFAS substances produced during the fluorination of plastic containers.

The petition alleges that the three PFAS—PFOA, PFNA, and PFDA—pose a variety of serious human health hazards, even at extremely low exposures.  The petition cites EPA’s December 2023 response to significant new use notices filed by Inhance Technologies (“Inhance”), a fluorination company, for substances including PFOA, PFNA, and PFDA.  As discussed in a previous blog post, EPA found that Inhance’s production of the three PFAS presents an unreasonable risk and ordered Inhance to stop producing the chemicals under TSCA section 5, which allows EPA to regulate new substances and significant new uses.

Inhance challenged EPA’s order.  In March, the Fifth Circuit ruled that EPA could not regulate Inhance under TSCA section 5 because Inhance’s fluorination process had been in place for decades; a blog post on the verdict can be found here.  However, the court noted that EPA is free to regulate Inhance’s fluorination process under section 6, which allows EPA to restrict existing substances.  Unlike section 5, section 6 requires EPA to conduct a cost-benefit analysis that considers a substance’s benefits and what the economic consequences of regulation would be.

In its letter granting the petition, EPA said that the agency will initiate “an appropriate proceeding under TSCA Section 6 associated with the formation” of the three PFAS during plastic container fluorination.  As part of the proceeding, “EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates PFOA, PFNA, and PFDA; and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers.”

FDA Reaffirms Softening Chemicals are Okay for Food Packaging

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FDA recently denied a citizen petition requesting that the Agency prohibit the use of eight ortho-phthalates and revoke prior sanctioned uses for five additional ortho-phthalates in food packaging. Ortho-phthalates are used to soften plastics. They can be found in plastic film wrap on foods, cap gaskets used on the metal lids of glass jars, beverage caps, and other packaging.

The original petition was submitted by Earthjustice in 2016. FDA responded in May 2022, denying the petition; Earthjustice submitted a petition for reconsideration in June of that same year. Earthjustice stated that it filed the petition for reconsideration because FDA needed to consider the “mounting scientific evidence that phthalates in food cause serious harm,” evidence that has been developed since the petition was originally submitted.  According to Earthjustice, there is now significant scientific evidence that links phthalates to fibroid tumors in women and preterm births.

The petition for reconsideration alleged that FDA ignored the scientific information presented within the original petition, did not take new information into consideration when denying the petition, and failed to take action on the use of phthalates. In its response to the petition for reconsideration, FDA maintained that it did, in fact, assess the scientific information presented in the original petition, which it did not find persuasive enough to change its position on phthalate regulation at this time.

Further, under 21 CFR § 10.33, FDA is only required to grant a petition for reconsideration if all the following criteria apply:

(1) The petition demonstrates that relevant information or views contained in the administrative record were not previously or not adequately considered.

(2) The petitioner’s position is not frivolous and is being pursued in good faith.

(3) The petitioner has demonstrated sound public policy grounds supporting reconsideration.

(4) Reconsideration is not outweighed by public health or other public interests.

The Agency holds that no information was presented in the petition that has not already been presented and is, therefore, in the administrative record. Because all of the above requirements must be met for reconsideration without the presentation of new relevant information in the petition, FDA has no further obligation at this time.