Inspections, Compliance, Enforcement, and Criminal Investigations
Tembec, Inc. 11-Sep-07
Department of Health and Human Services
Public Health Service
Cincinnati District Office
Via Federal Express
September 11, 2007
WARNING LETTER CIN-DO 07-33572-18
James M. Lopez, President and Chief Executive Officer
10, Chemin Gatineau
Temiscaming, QC JoZ 3Ro
Dear Mr. Lopez:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Tembec BTLSR, Inc. located at 2112 Sylvan Ave., Toledo, Ohio, on May 21 - June 15, 2007. The inspection revealed significant deviations from the Federal Food, Drug, and Cosmetic Act (the Act).
Your firm's feed binding agents, RW25 (marketed under the label names A. Mas and Dresbond AC), RW26 (also marketed under the label names Aqua-Tech II and Aquabond CM), and UP60 (marketed under the label name Dresbond AC), are adulterated within the meaning of sections 402(a)(2)(C)(i) and 402(a)(4) of the Act [21 U.S.C. § 342(a)(2)(C)(i) and (a)(4)]. In addition, your firm's product RW26 is misbranded within the meaning of section 403(i) of the Act [21 U.S.C. § 343(i)]. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
Specifically, the inspection found that you manufacture products using several unapproved food additives. First, your firm added melamine to RW26 from February 2004 until April 13, 2007. Samples of RW26 collected and analyzed by FDA revealed significant levels of melamine in this product. Second, your firm added urea formaldehyde condensation polymer to RW25, RW26, and UP60. Third, your firm added hexamethylenetetramine to certain batches of RW26. Under the Act, any substance intentionally added to a food must be used in accordance with a food additive regulation, unless it is generally recognized as safe ("GRAS") or meets one of the enumerated exceptions . Under section 409 of the Act [21 U.S.C. § 349], food additives are deemed unsafe unless they are used in accordance with a food additive regulation approving the substance for that use. Neither melamine, urea formaldehyde condensation polymer, nor hexamethylenetetramine are approved food additives, and we are not aware of any basis to conclude that they are GRAS for use in animal feed. The presence of these unsafe food additives in your products causes your products to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)].
In addition, the ingredient lists on the labels for the RW26 bulk product, Aqua-Tech II and Aquabond CM (products using RW26) did not disclose the presence of melamine. The failure to disclose this information on the label of your products causes those products to be misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], because they are fabricated from two or more ingredients and their labels fail to declare the common or usual name of each ingredient.
During the inspection it was also discovered that the animal feed products are manufactured on the same equipment used to manufacture industrial grade resin products; however, there are no procedures to clean-out the equipment between batches of animal feed products and industrial grade resins. Moreover, the investigators observed a build up of debris and resin on this equipment. Samples of RW25 and UP60 indicated that they had been cross-contaminated with melamine from the industrial grade products. Food produced under these conditions is adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
This letter may not be an all inclusive list of violations at your facility. It is your responsibility to ensure that your establishment is in compliance with all requirements of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. Failure to promptly correct violations may result in regulatory action being initiated by the Food and Drug Administration without further notice, such as seizure and/or injunction.
We acknowledge receipt of the Tembec BTLSR, Inc. response dated June 29, 2007, signed by the Plant Manager, James F. Anderson. The letter states that Tembec BTLSR, Inc. is recalling all feed binding agents shipped since February 2004, due to the presence of melamine, an unapproved food additive. Also, the letter states that Tembec BTLSR, Inc. has decided to permanently discontinue manufacturing any products regulated by FDA. Given the seriousness of these violations, FDA is requesting confirmation in writing from a Tembec, Inc. official who is authorized to make the decision to permanently discontinue manufacturing feed binding agents.
You should submit your written response to this office within fifteen (15) working days of receipt of this letter. Your response should include each step you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the U.S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Compliance Officer Sego at (513) 679-2700 extension 164.
Carol A. Heppe
Tembec BTLSR, Inc. response to FDA