Proposed Rules. Notification; extension of comment period

Agency: Food and Drug Administration, HHS
Action: Notification; extension of comment period
Citation: FR Doc. 2016-03708 · Docket No. FDA-2015-F-4317 · 21 CFR 172

Summary

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of filing that appeared in the Federal Register of January 4, 2016. In the notice, FDA requested comments on a filed food additive petition (FAP 5A4810), submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Dates

We are extending the comment period on the notice of filing of a food additive petition published on January 4, 2016 (81 FR 42). Submit either electronic or written comments by May 3, 2016.

Supplementary Information

In the Federal Register of January 4, 2016 (81 FR 42), we published a notice of filing of a food additive petition (FAP 5A4810) submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, c/o Mr. Thomas Neltner, 1875 Connecticut Ave. NW., Suite 600, Washington, DC 20009. The notice also invited comments on the petition. The petition proposes to amend 21 CFR 172.515, Synthetic flavoring substances and adjuvants, to no longer provide for the use of seven listed synthetic flavoring food additives and to establish zero tolerances for these additives. Specifically, the petitioners contend that new data establish that these substances are carcinogenic and are, therefore, not safe for use in food pursuant to the Delaney Clause (section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)(3)(A))), which provides that no food additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal. The seven food additives which are the subject of the petition are: • Benzophenone (also known as diphenylketone) (CAS No. 119-61-9); • Ethyl acrylate (CAS No. 140-88-5); • Eugenyl methyl ether (also known as 4-allylveratrole or methyl eugenol) (CAS No. 93-15-2); • Myrcene (also known as 7-methyl-3-methylene-1,6-octadiene) (CAS No. 123-35-3); • Pulegone (also known as p -menth-4(8)-en-3-one) (CAS No. 89-82-7); • Pyridine (CAS No. 110-86-1); and • Styrene (CAS No. 100-42-5). We have received a request for a 60-day extension of the comment period for the petition. The request conveyed concern that the current 60-day comment period does not allow sufficient time to collect and provide data and information and develop a meaningful and thoughtful response to the assertions set forth in the petition. We have considered the request and are extending the comment period for the petition for an additional 60 days, until May 3, 2016. We believe that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. Dated: February 18, 2016. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2016-03708 Filed 2-22-16; 8:45 am]