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.