Letter to E. I du Pont de Nemours and Company Acknowledging Receipt of the Voluntary Commitment for Food Contact Substances (FCS)
Below is the letter acknowledging FDA's receipt of the Commitment Letter from E. I. DuPont de Nemours & Co Documenting Cessation of Introduction into Interstate Commerce.
|DEPARTMENT OF HEALTH & HUMAN SERVICES||Public Health Service|
| Food and Drug Administration |
College Park, MD 20740
June 25, 2012
Keller and Heckman, LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001
Dear Mr. Misko:
The purpose of this letter is to acknowledge the receipt of the voluntary commitment made by your client, E. I du Pont de Nemours and Company, (herinafter “DuPont”) for the following two food contact substances (FCSs) “Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 247047-61-6)” which is the subject of effective premarket notifications (FCNs) 206, 311, and 338; and “Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid (CAS Reg. No. 870465-08-0)” which is the subject of FCN 646. This commitment, as stated in the correspondence of November 16, 2011, confirms that DuPont ceased introduction into interstate commerce or delivery for introduction into interstate commerce of these FCSs for any use in food-contact applications which are subject to the jurisdiction of the FDA as of September 1, 2009, and that DuPont will not thereafter introduce into interstate commerce or deliver for introduction these FCSs for any use in food-contact applications subject to the jurisdiction of the FDA.
Under Section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act, “the term ‘food contact substance’ means the substance that is the subject of a notification... and does not include a similar or identical substance manufactured or prepared by a person other than the manufacturer identified in the notification.” DuPont is listed as the manufacturer/supplier in FCNs 206, 311, 338, and 646. Therefore, in accordance with 21 U.S.C. § 348(h)(2)(C), these effective FCNs apply only to the FCSs that are the subject of FCNs 206, 311, 338, and 646 and that are manufactured or prepared by DuPont.
These FCSs belong to a class of compounds termed long-chain perfluorinated compounds (compounds with extended perfluorinated chains 8 carbon atoms in length or longer). FDA is conducting an ongoing comprehensive review of long-chain perfluorinated compounds. FDA’s assessment of the available data on these types of compounds has indicated the need to consider factors in addition to those traditionally considered by the Agency at similar exposure levels. These include additional possible toxic endpoints (e.g., effects on pre- and post-natal development and reproductive health and function), perfluorinated carbon chain lengths, and appropriate animal models.
FDA previously informed DuPont that additional safety testing is required to support the continued effectiveness of FCNs 206, 311, 338, and 646. This determination was based on data which became available after these FCNs became effective which demonstrates biopersistence of the starting monomer for these FCSs, the low molecular weight oligomeric (LMWO) constituents of these FCSs, and the LMWO constituents of a close structural analogue to these FCSs. This evidence of biopersistence is combined with a lack of testing to address data which demonstrates systemic toxicity for compounds similar in chemical structure to the LMWO constituents of these FCSs, as well as the additional toxic endpoints relevant to long-chain perfluorinated compounds discussed above. FDA also informed DuPont that testing to address these safety concerns would need to be of an extended nature to account for body burden levels resulting from chronic exposure to potentially biopersistent LMWO constituents of these FCSs.,  Although DuPont expressed their disagreement with FDA’s determination that additional safety testing is necessary,,  nonetheless the company voluntarily ceased introduction or delivery for introduction of the products covered by FCNs 206, 311, 338, and 646 into interstate commerce for use in any food-contact applications subject to the jurisdiction of the FDA.
The current correspondence confirms receipt by the FDA of the letter dated November 16, 2011, in which DuPont confirms that introduction of the FCS subject of FCNs 206, 311, and 338 into interstate commerce or delivery for introduction into interstate commerce ceased as of September 1, 2009, and that the FCS subject to FCN 646 was never introduced or delivered for introduction into interstate commerce in the United States. DuPont’s letter also states the company’s commitment that it will not thereafter introduce these FCSs into interstate commerce or deliver these FCSs for introduction into interstate commerce for any use in food-contact applications subject to the jurisdiction of the FDA.
DuPont has stated its belief that, as a result of its voluntary commitment the large majority of existing stocks of the neat FCSs, paper and paperboard coated with these FCSs, and food packaged in paper coated with these FCSs are no longer available in commerce.1 As such, FDA estimates that little to no additional consumer exposure to these FCSs will occur as of the date of the current correspondence.
FDA maintains an Inventory of Effective Food-Contact Notifications on FDA’s website. FDA intends to update this inventory to reflect the actions and confirmation by DuPont with respect to these FCNs.
Office of Food Additive Safety, HFS-200
Center for Food Safety and Applied Nutrition
 Letter from John W. Moriarty (DuPont Chemicals & Fluoroproducts) to Mitchell Cheeseman (FDA) dated November 16, 2011.
Letter from Francis Lin (FDA) to Stephen Korzeniowski (DuPont Chemical Solutions Enterprise) dated March 4, 2008.
3]Letter from Mitchell Cheeseman (FDA) to George Misko (Keller and Heckman, LLP) dated December 9, 2010.
4] Letter from Mitchell Cheeseman (FDA) to George Misko (Keller and Heckman, LLP) dated January 25, 2011.
 Letter from George Misko (Keller and Heckman, LLP) to Francis Lin (FDA) dated June 9, 2008.
Letter from George Misko (Keller and Heckman, LLP) to Mitchell Cheeseman (FDA) dated January 24, 2011.
 “Inventory of Effective Food Contact Substance (FCS) Notifications”. This document can be accessed in the Food Ingredients and Packaging section under the Food topic on the Agency’s internet site at http://www.fda.gov.