FDA Warns Tembec About Violations At Animal Feed Plant

In May of this year, Tembec was under fire for adding melamine as a binding agent in livestock, fish, and shrimp feed. The feed was used for both domestic use and was exported to 13 other countries. A recall on the animal feed was issued because of the use of melamine.

Melamine was found to improve binding of ingredients used to make food pellets, but it is not approved as a food additive.

In June, media outlets also reported that Tembec did not even have a license to produce animal feed components.

Now, the FDA is warning Tembec about violations at their Toledo, Ohio plant.

In a letter dated September 11, the FDA said the facility is making feed-binding agents that contains additives not approved as safe, including significant levels of melamine. The agency also mentions faulty cleaning of equipment used for both resins and animal feed products.

Tembec has told the FDA that they will stop making products regulated by the FDA.

Here is the letter that the FDA wrote to Tembec in regards to their violations:

September 11, 2007

WARNING LETTER CIN-DO 07-33572-18

James M. Lopez, President and Chief Executive Officer
Tembec, Inc.
10, Chemin Gatineau
C.P.5000
Temiscaming, QC JoZ 3Ro
Canada

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.

Sincerely,

/S/

Carol A. Heppe
District Director
Cincinnati District

Source: Reuters, FDA

(Thanks menusux)

9 Responses to “FDA Warns Tembec About Violations At Animal Feed Plant”

  1. thomas says:

    Why not make them post whom they sold these products to . Three years and maybe more of selling unapproved crap to be used in feeds. Why not just lock the doors on this company?

  2. Sharon says:

    This company needs to be shut down permanently. Apparently there are no legal consequences for poisoning people in 13 countries for 4 years.

  3. purringfur says:

    SHUT DOWN TEMBEC IMMEDIATELY! IT WAS NEVER LICENSED TO MAKE ANIMAL FEEDS IN THE FIRST PLACE!!!

    Would anyone trust this company for ANYTHING if it was involved in ILLEGAL PRODUCTION OF PRODUCTS?

    I hope they don’t make bathroom tissue (TP) from their wood!

    TEMBEC - “A Canadian Integrated Forests Products Company”

    Tembec: Stick with your forest products, and GET WAY AWAY FROM ANIMAL FEEDS!

    In their intro., a pair of cupped hands holds a beautiful forest. What garbage!

    TEMBEC Contact Info:

    Head Office

    Tembec Inc.
    800, boul. René-Lévesque Ouest - Bureau 1050
    Montréal, QC H3B 1X9
    Canada
    Tel: (514) 871-0137
    Fax: (514) 397-0896

    Corporate Office

    Tembec Inc.
    10, chemin Gatineau,
    C.P. 5000
    Témiscaming, QC J0Z 3R0
    Canada
    Tél: (819) 627-4387
    Fax: (819) 627-1178

    From the FDA Warning Letter:

    “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)].”
    [GRAS means Generally Regarded as Safe.]

    And this has been going on for 3 YEARS?

    TEMBEC shuts down some sawmills:

    http://www.tembec.com/public/S.....search=all

    “The curtailments are in addition to existing shutdowns in Eastern Canada at the Company’s facilities in Timmins and Kirkland Lake, Ontario and La Sarre and Béarn, Quebec.”

    http://www.tembec.com/public/S.....search=all

    It would be wonderful for Tembec to go belly up for producing animal feed, for which it never had a license.

    Does anyone know if these unsafe substances listed are wastes of sawmills to produce various wood products?

    This illegal production has been going on for years, and we’re the ones (and the animals for human consumption) paying the price through slow poisoning.

    Just think of all the other horrendous things we DON’T KNOW ABOUT YET!

  4. Trudy Jackson says:

    What food have they put out? Does anyone know?
    This is terrible.

  5. Trudy Jackson says:

    I guess that was a dumb question. Menu foods, of course. I “think” they make the Friskies I was feeding.

  6. Jenny Bark says:

    I agree with all of you, they should have already been shut down, but of cource their not. Just keep selling the poisen untill all your stuff is gone. Our American gov is so great at protecting us-NOT.

  7. Katie says:

    I agree with all of you too. They should have been shut down, long ago. You gotta love Tembec’s answer - we just won’t make products the FDA regulates!!!

    Katie

  8. Tembec Withdraws From Animal Feed Business | Itchmo: News For Dogs & Cats says:

    […] FDA then warned the company earlier this month about using additives not approved as safe, including melamine, at their Toledo, Ohio […]

  9. Concha Castaneda says:

    Hopefully they arn’t making the Hamburger that has just been recalled.


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