Below is the letter acknowledging FDA's receipt of the Commitment Letter from Clariant Corporation Documenting Cessation of Introduction into Interstate Commerce (PDF: 2.7 MB).

June 25, 2012

George Misko
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, Clariant Corporation (herinafter “Clariant”) for the following food contact substance (FCS) “Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate (CAS Reg. No. 479029-28-2)” which is the subject of the effective premarket notification (FCN) 628. This commitment, as stated in their correspondence [1] of September 1, 2011, confirms that Clariant ceased introduction into interstate commerce or delivery for introduction into interstate commerce of this FCS for any use in food-contact applications which are subject to the jurisdiction of the FDA as of August 31, 2011, and that Clariant will not thereafter introduce into interstate commerce or deliver for introduction this FCS 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.” Clariant is listed as the manufacturer/supplier in FCN 628. Therefore, in accordance with 21 U.S.C. § 348(h)(2)(C), this effective FCN applies only to the FCS that is the subject of this FCN and are manufactured or prepared by Clariant.

This FCS belongs 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 Clariant that additional safety testing is required to support the continued effectiveness of FCN 628.[2] This determination was based on data which became available after the FCN became effective which demonstrate systemic toxicity for compounds similar in chemical structure to the low molecular weight constituents of the FCS, combined with data which demonstrates biopersistence of the starting monomer for the commercial FCS and a lack of information specific to the low molecular weight constituents of the FCS to address the additional toxic endpoints relevant to long-chain perfluorinated compounds discussed above. FDA also informed Clariant 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.[3] Although Clariant expressed their disagreement with FDA’s determination that additional safety testing is necessary,[4] nonetheless the company voluntarily ceased introduction or delivery for introduction into interstate commerce of any product covered by FCN 628 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 September 1, 2011, in which Clariant confirms that introduction of the FCS subject of FCN 628 into interstate commerce or delivery for introduction into interstate commerce ceased as of August 31, 2011. Clariant’s letter also states the company’s commitment that it will not thereafter introduce the FCS into interstate commerce or deliver the FCS for introduction into interstate commerce for any use in food-contact applications subject to the jurisdiction of the FDA.

Clariant has stated that, based upon its experience with the usage of such products by companies further down the supply chain, the large majority of existing stocks of the neat FCS, paper and paperboard coated with the FCS, and food packaged in paper coated with the FCS will be exhausted within one year of the cessation of initial introduction into interstate commerce.1 Therefore, consumer exposure to the FCS is expected to rapidly decrease, and FDA estimates that little to no additional exposure will occur 1 year after the cessation of initial introduction. FDA has considered the exposure to the FCS that will occur during this one-year period and has determined that such exposure will not result in an appreciable increase in existing body burden levels. Therefore, the exposure to the FCS that will occur during this period is not expected to have a significant impact on public health.

FDA maintains an Inventory of Effective Food-Contact Notifications on FDA's website.[5] FDA intends to update this inventory to reflect the actions and confirmation by Clariant with respect to this FCN.

Sincerely,

/S/

Dennis M. Keefe
Director
Office of Food Additive Safety, HFS-200
Center for Food Safety and Applied Nutrition

[1] Letter from Kenneth L. Golder (Clariant Corporation) and Helmut Wagner (Clariant Corporation) to Mitchell Cheeseman (FDA) dated September 1, 2011.
[2] Letter from Francis Lin (FDA) to Daria Churach (Clariant Corporation) dated March 4, 2008.
[3] Letter from Mitchell Cheeseman (FDA) to George Misko (Keller and Heckman, LLP) dated December 3, 2010.
[4] Letter from George Misko (Keller and Heckman, LLP) to Francis Lin (FDA) dated June 13, 2008.
[5] "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.