2022-14682. Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of petition.

SUMMARY:

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University, proposing that the food additive regulations be amended to remove or restrict authorizations for the use of bisphenol A (BPA).

DATES:

The food additive petition was filed on May 2, 2022. Submit either electronic or written comments on the filing notice by September 9, 2022.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 9, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2022-F-1108 for “Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University; Filing of Food Additive Petition.” Received comments, those filed in a timely manner (see DATES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:

Marissa Santos, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-8160.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 2B4831), submitted by Environmental Defense Fund, Maricel Maffini, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group, Healthy Babies Bright Futures, Linda Birnbaum, and the Nicholas School of the Environment at Duke University, c/o Mr. Thomas Neltner, 1875 Connecticut Ave. NW, Washington, DC 20009. The petition proposes to amend the food additive regulations in §§ 175.105, 175.300, 177.1440, 177.1580, 177.1585, 177.2280, and 177.2440 (21 CFR 175.105, 175.300, 177.1440, 177.1580, 177.1585, 177.2280, and 177.2440); Indirect Food Additives: General (part 174 (21 CFR part 174)); Indirect Food Additives: Adhesives and Components of Coatings (21 CFR part 175); and Indirect Food Additives: Polymers (21 CFR part 177), to remove authorizations for the use of BPA in §§ 175.105, 175.300, and 177.2440; establish a migration limit for BPA from the authorized uses of BPA in food contact articles in §§ 177.1440, 177.1580, 177.1585, and 177.2280; and add a new provision to part 174 with a restriction on the use of BPA, stating that the substance is subject to a specific migration limit of 0.5 nanograms per kilogram of food. The petition is available in Docket No. FDA-2022-F-1108.

II. Amendment of §§ 175.105, 175.300, 177.1440, 177.1580, 177.1585, 177.2280, and 177.2440 and Addition of New Provision With BPA Restriction

In accordance with the procedures for amending or repealing a food additive regulation in §  171.130 (21 CFR 171.130), the petition asks us to amend §§ 175.105, 175.300, 177.1440, 177.1580, 177.1585, 177.2280, and 177.2440 to remove authorizations for the use of BPA in §§ 175.105, 175.300, and 177.2440; establish a migration limit for BPA from the authorized uses of BPA in food contact articles in §§ 177.1440, 177.1580, 177.1585, and 177.2280; and add a new provision to part 174 with a restriction on the use of BPA. The petitioners cite, as evidence, a draft opinion by the European Food Safety Authority (EFSA), which analyzed studies related to the health effects of dietary BPA exposure that were published between January 1, 2013, through October 15, 2018. EFSA's draft opinion entitled “Re-evaluation of the risks to public health related to the presence of bisphenol (BPA) in foodstuffs,” was published in December 2021 for public comment. Based on the analysis in the draft EFSA opinion, the petitioners conclude that the use of BPA in food and food contact articles is toxic and disrupts the “proper functioning of the immune and reproductive systems.” To support their conclusion, the petitioners also cite publications referred to in comments to EFSA on the draft opinion and an epidemiology study that petitioners assert show an association of in utero exposure to BPA with an increased risk of asthma and wheezing in school-age girls.

We invite comments, additional scientific data, and other information related to the issues raised by this petition. If we determine that the available data justify removing authorizations for the use of BPA as listed under §§ 175.105, 175.300, and 177.2440; establishing a migration limit for BPA from authorized uses of BPA in food contact articles as listed under §§ 177.1440, 177.1580, 177.1585, and 177.2280; or adding a new provision with a restriction on the use of BPA, we will publish our decision in the Federal Register in accordance with §  171.130.

The petitioners have claimed that this action is categorically excluded under 21 CFR 25.32(m) because this action would prohibit or otherwise restrict the use of a substance in food packaging. In addition, the petitioners have stated that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.

Dated: July 1, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.