Environmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearing

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 175, 176, 177, and 178</CFR> <DEPDOC>[Docket No. FDA-2016-F-1253]</DEPDOC> <SUBJECT>Environmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearing</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notification; response to objections and denial of public hearing requests. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by the Environmental Defense Fund, Learning Disabilities Association of America, Center for Food Safety, Center for Environmental Health, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Defend our Health, and Alaska Community Action on Toxics on the denial of a food additive petition (FAP 6B4815) requesting that we revoke specified regulations to no longer provide for the food contact use of 28 <E T="03">ortho</E> -phthalates. We are overruling the objections and denying the requests for a public hearing. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> October 30, 2024. </DATES> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Jessica Urbelis, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-5187; or Carrol Bascus, Office of Policy, Regulations and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> In the <E T="04">Federal Register</E> of May 20, 2016 (81 FR 31877), we announced the filing of a food additive petition (FAP 6B4815) (petition) submitted by the Breast Cancer Fund (now Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council (hereinafter, petitioners). The petition, received March 18, 2016, initially requested that we amend or revoke specified food additive regulations under parts 175, 176, 177, and 178 (21 CFR parts 175, 176, 177, and 178) to no longer provide for the food contact uses of 30 substances that the petition identified as <E T="03">ortho</E> -phthalates. Additionally, petitioners requested that we amend regulations in part 181 (21 CFR part 181) related to prior-sanctioned uses of five <E T="03">ortho</E> -phthalates and issue a new regulation in part 189 (21 CFR part 189) prohibiting the use of eight specific <E T="03">ortho</E> -phthalates in food contact articles. We declined to file these portions of the submissions as a food additive petition because those requests were not within the scope of a food additive petition (81 FR 31877 at 31878). Following our May 20, 2016, announcement that we had filed the food additive petition, the petitioners provided supplementary information on October 8, 2016, and August 24, 2017 (see FAP 6B4815 regarding <E T="03">ortho</E> -phthalates/Responses to September 1, 2016, request from Tom Neltner, Breast Cancer Fund, et al., dated October 8, 2016, and August 24, 2017) (Supp., October 8, 2016, and Supp., August 24, 2017, respectively). In the October 8, 2016, supplement, the petitioners also requested that FDA remove two substances from the petitioner's original list of 30 substances, stating that they are not <E T="03">ortho</E> -phthalates (Supp., October 8, 2016 at 2). Consequently, the subject of the food additive petition was limited to food additive regulations for 28 <E T="03">ortho</E> -phthalates. In addition, regarding the certain portions of the submissions that we declined to file as a food additive petition because those requests were not within the scope of a food additive petition, on April 19, 2016, the petitioners submitted a citizen petition containing those requests (see Citizen Petition from Nancy Buermeyer, Breast Cancer Fund, et al., submitted to the Dockets Management Staff, Food and Drug Administration, dated April 19, 2016 (Comment ID FDA-2016-P-1171-0001) (citizen petition). Specifically, the citizen petition requested that we initiate rulemaking to remove the prior sanctions in part 181 for five <E T="03">ortho</E> -phthalates and that we add a new section to part 189 prohibiting the use of eight <E T="03">ortho</E> -phthalates (citizen petition at 1 through 2). On May 12, 2022, we denied the citizen petition. The core premise of FAP 6B4815 was that the 28 subject <E T="03">ortho</E> -phthalates are chemically and pharmacologically related and should therefore be treated as a class for purposes of evaluating their safety. The petitioners argued that a single purported acceptable daily intake (ADI) for one substance should be applied to the purported class of 28 <E T="03">ortho</E> -phthalates and that the cumulative exposure to all 28 <E T="03">ortho</E> -phthalates significantly exceeded the purported ADI for the one substance petitioners selected, thereby rendering the entire purported class unsafe for use as food additives. In the <E T="04">Federal Register</E> of May 20, 2022 (87 FR 31066), we announced that we were denying FAP 6B4815. In that <E T="04">Federal Register</E> document (hereinafter, denial order), we explained that the petition did not provide sufficient information to support a finding that there is no longer a reasonable certainty of no harm for the authorized uses of the proposed class of 28 <E T="03">ortho</E> -phthalates. As an additional matter, based on the information available to FDA, the denial order stated that we did not have a basis to conclude that dietary exposure levels from the authorized <E T="03">ortho-</E> phthalates exceed a safe level (87 FR 31066 at 31075). The denial order advised that objections and requests for a hearing were due by June 21, 2022 (87 FR 31066). Subsequently, we received one submission from a group of eight objectors that raised several objections and requests for hearing in response to the denial order. Following receipt of FAP 6B4815 in March 2016, on June 25, 2018, we received a food additive petition (FAP 8B4820) submitted by the Flexible Vinyl Alliance (hereinafter, the abandonment petition). The abandonment petition proposed that we amend our food additive regulations in parts 175, 176, 177, and 178 to revoke the approvals of 25 plasticizer substances that the petition identified as <E T="03">ortho</E> -phthalates for various food contact applications because such uses were permanently abandoned. In response to the abandonment petition, we issued a final rule on May 20, 2022 (87 FR 31080) amending the food additive regulations in parts 175, 176, 177, and 178 to revoke the authorization of the 25 substances that were the subject of the petition for various food contact applications (the abandonment final order). FDA issued the abandonment final order concurrently with its denial order for FAP 6B4815. On May 20, 2022, we also issued a request for information (RFI) seeking scientific data and information on current uses, use levels, dietary exposure, and safety data for <E T="03">ortho</E> -phthalates that remain authorized for use in food contact applications (87 FR 31090). The objections and requests for hearing we received refer to the denial order, citizen petition, abandonment final order, and RFI. <E T="03">Ortho</E> -phthalates also are included on FDA's list of chemicals in the food supply that are under review (see <E T="03">https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review</E> ). We are committed to continuing the evaluation of all relevant scientific information and data to determine whether additional regulatory action regarding <E T="03">ortho</E> -phthalates is warranted to ensure the safety of all authorized food contact uses of <E T="03">ortho</E> -phthalates. <HD SOURCE="HD1">II. Objections and Requests for Hearing</HD> Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after publication of an order denying a food additive petition, any person adversely affected by such order may file objections, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. Under our regulations at 21 CFR 171.110, objections and requests for a hearing relating to food additive regulations are governed by part 12 (21 CFR part 12). Under § 12.22(a), each objection must: (1) be submitted on or before the 30th day after the date of publication of the final rule; (2) be separately numbered; (3) specify with particularity the provision of the regulation or proposed order objected to; (4) specifically state each objection on which a hearing is requested (failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection); and (5) include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested (failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection). We received one submission, on June 21, 2022, from the Environmental Defense Fund, Learning Disabilities Association of America, Center for Food Safety, Center for Environmental Health, Center for Science in the Public Interest, Breast Cancer Pre ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 118k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━