Below is the letter acknowledging FDA's receipt of the Commitment Letter from BASF Corporation Documenting Cessation of Introduction into Interstate Commerce (PDF: 570 kB).

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration
College Park, MD 20740

June 25, 2012

Theodore Kelly, Jr.
Vice President
Wet End Chemicals
Paper Chemicals Division
BASF Corporation
11501 Steele Creek Road
Charlotte, NC 28273

Dear Mr. Kelly:

The purpose of this letter is to acknowledge the receipt of the voluntary commitment made by BASF Corporation, (herinafter “BASF”) for the following two food contact substances (FCSs) “3-cyclohexene-1-carboxylic acid, 6-[(di-2-propenylamino) carbonyl]-, sodium salt, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, ammonium salts (CAS Reg. No. 392286-82-7)” which is the subject of effective premarket notification (FCN) 255; and “Glycine, N,N-bis[2-hydroxy-3-(2-propenyloxy)propyl]-, monosodium salt, reaction products with ammonium hydroxide and pentafluoroiodoethane-tetrafluoroethylene telomer (CAS Reg. No. 220459-70-1)” which is the subject of FCN 59. This commitment, as stated in your correspondence[1] of November 28, 2011, confirms that BASF 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 October 1, 2011, and that BASF 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.” The original notifier for FCNs 59 and 255 was Ciba Specialty Chemicals Corporation, which is listed as the manufacturer/supplier for these FCNs on the Inventory of Effective Food-Contact Notifications on FDA’s website. Ciba Specialty Chemicals Corporation was acquired by BASF in September 2008, and, as such, FDA considers BASF to be the manufacturer/supplier for FCNs 59 and 255. 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 59 and 255 and that are manufactured or prepared by BASF.

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 BASF that additional safety testing is required to support the continued effectiveness of FCNs 59 and 255.[2] FDA also informed BASF 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 these biopersistent FCSs.[5], [6] Although BASF expressed their disagreement with FDA’s determination that additional safety testing is necessary,[7], [8] nonetheless the company voluntarily ceased introduction or delivery for introduction of the products covered by FCNs 59 and 255 into interstate commerce for use in any food-contact applications subject to the jurisdiction of the FDA., [3], [4] This determination was based on data which became available after these FCNs became effective which demonstrates liver toxicity and biopersistence of the commercial FCSs or similar compounds, as well as a lack of data to address the additional toxic endpoints relevant to long-chain perfluorinated compounds discussed above.

The current correspondence confirms receipt by the FDA of the letter dated November 28, 2011, in which BASF confirms that introduction of the FCSs subject of FCNs 59 and 255 into interstate commerce or delivery for introduction into interstate commerce ceased as of October 1, 2011. BASF’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.

BASF 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 FCSs, paper and paperboard coated with these FCSs, and food packaged in paper coated with these FCSs will be exhausted within one year of the cessation of initial introduction into interstate commerce. Therefore, consumer exposure to these FCSs 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 these FCSs 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 these FCSs 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.[9] FDA intends to update this inventory to reflect the actions and confirmation by BASF with respect to these FCNs.

Sincerely,

/S/

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

[1] Letter from Theodore Kelly, Jr. (BASF Corporation) to Mitchell Cheeseman (FDA) dated November 28, 2011.
[2] Letter from Mitchell Cheeseman (FDA) to M. Alfred Wiedow (BASF Corporation) dated December 3, 2010.
[3] Second Letter from Mitchell Cheeseman (FDA) to M. Alfred Wiedow (BASF Corporation) dated December 3, 2010.
[4] Letter from Mitchell Cheeseman (FDA) to M. Alfred Wiedow (BASF Corporation) dated December 29, 2010.
[5] Letter from Francis Lin (FDA) to M. Alfred Wiedow (Ciba Specialty Chemicals Corporation) dated October 8, 2008.
[6] Letter from Francis Lin (FDA) to M. Alfred Wiedow (Ciba Specialty Chemicals Corporation) dated October 9, 2008.
[7] Letter from M. Alfred Wiedow (BASF Corporation) to Mitchell Cheeseman (FDA) dated December 17, 2010.
[8] Letter from M. Alfred Wiedow (BASF Corporation) to Mitchell Cheeseman (FDA) dated January 18, 2011.
[9] “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.