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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - September and October 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No V

Warning Letters

The Food and Drug Administration issued a WARNING LETTER to Jim Wilson, John Wilson, partners, and to Wesley S. Killion, Feedlot Manager of Beef Northwest Feeders LLC of Boardman, OR, for violations of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the firm sold a steer for slaughter as food that was found to have residues of the drug sulfadimethoxine at 2.13 parts per million (ppm) in the liver tissue and 1.20 ppm in the muscle tissue. A second steer that was sold by the firm was found to have residues of the same drug at 1.36 ppm in the liver tissue and 1.17 ppm in the muscle tissue. A tolerance of 0.1 ppm has been established by FDA for residues of sulfadimethoxine in the uncooked edible tissues (21 Code of Federal Regulations [CFR] 556.640(b)). Having exceeded the established tolerance, both animals were adulterated under section 402(a) of the FFDCA. The firm was also found to have administered Albon® S.R. (sulfadimethoxine) sustained release bolus without following the pre-slaughter withdrawal time set forth in the approved labeling, and it did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the extralabel use resulted in an illegal drug residue. Because the extralabel use of this drug was not in compliance with 21 CFR 530, the drug was also unsafe under section 512(a) of the FFDCA.

Christopher J. Elbe, owner of the Chris and Tracey Elbe Dairy Farm of West Bend, WI, received a WARNING LETTER from FDA for offering an animal for sale that was adulterated under section 402(a) of the FFDCA. Specifically, the firm shipped a dairy cow for slaughter as food that was found to have residues of penicillin at 0.49 ppm in the kidney tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the uncooked edible tissues of cattle as codified in 21 CFR 556.510. The presence of this drug in kidney tissue from this animal in this amount caused the food to be adulterated within the meaning of section 402(a) of the FFDCA. The firm also failed to maintain animal treatment records and it lacked an adequate inventory system for determining the quantities of drugs used to medicate its livestock.

Similar violations of the adulteration provisions of the FFDCA were cited in a WARNING LETTER from FDA to Edward J. Eury, Jr., of Knoxville, MD, who sold a veal calf for slaughter as food. Tissue samples of the animal revealed the presence of 4.39 ppm of sulfamethazine in the muscle tissue and 5.98 ppm in the liver tissue. A second veal calf that was also sold for food was shown to have 15.80 ppm of the same drug in the muscle tissue and 22.01 ppm in the liver tissue. In addition, this animal was found to have residues of the drug neomycin in the kidney tissue at 69.27 ppm. These drug levels all exceeded the tolerances established by FDA in 21 CFR Part 556 and rendered the animals adulterated under section 402(a) of the FFDCA.

FDA issued a WARNING LETTER to James M. Lopez, President and Chief Executive Officer of Tembec, Inc., of Quebec, Canada, for violations of the adulteration and misbranding provisions of the FFDCA. The 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), were adulterated within the meaning of section 402(a) of the Act. In addition, the firm’s product, RW26, was misbranded within the meaning of section 403(i). Specifically, an FDA inspection found that the firm manufactured products using several unapproved food additives. First, it added melamine to RW26, and second, it added urea formaldehyde condensation polymer to RW25, RW26, and UP60. Third, the firm added hexamethylenetetramine to certain batches of RW26. Under the FFDCA, 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. Melamine, urea formaldehyde condensation polymer, and hexamethylenetetramine are not approved food additives, and FDA is not aware of any basis to conclude that they are GRAS for use in animal feed. The presence of these unsafe food additives in the products caused them to be adulterated under section 402(a)(2)(C)(i) of the Act. 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 the products caused them to be misbranded under section 403(i)(2) of the Act because they were fabricated from two or more ingredients and their labels failed to declare the common or usual name of each ingredient.

Duane K. Oxendale, owner of Duane Oxendale finishing operation, received a WARNING LETTER from FDA for violation of the adulteration provision in section 402(a) of the FFDCA. Specifically, Mr. Oxendale sold a heifer that was slaughtered for human food that was found to contain 40.96 ppm sulfamethazine in the liver and 23.91 ppm of the drug in the muscle. A tolerance of 0.1 ppm has been established by FDA for residues of sulfamethazine in the uncooked edible tissues of cattle (21 CFR 556.670). These higher levels rendered the animal adulterated. Mr. Oxendale was also warned of providing a false guaranty, a prohibited act under section 301(h) of the FFDCA. He was also cited for failure to maintain treatment records.

FDA issued a WARNING LETTER to Matthew Toms, owner of Matthew Toms dairy operation, Walkersville, MD, for violations of the adulteration provisions of sections 402(a) and 501(a) and of the safety provision in section 512(a) of the FFDCA. Specifically, Mr. Toms consigned a culled adult dairy cow for slaughter as food through a hauler. Tissue samples taken by USDA inspectors revealed the presence of the drug penicillin at 0.17 ppm in the kidney tissue. A tolerance of 0.05 ppm has been established for this drug in the uncooked edible tissues of cattle (21 CFR 556. 510). The higher level rendered the meat adulterated under section 402(a). In addition, Mr. Toms was cited for failure to use penicillin in conformance with its approved labeling in violation of section 501(a) of the FFDCA. The drug was also used extralabel in violation of section 512(a) of the FFDCA, because such use was not done under the supervision of a licensed veterinarian.

Bryan Vander Dussen, Partner in Golden View LP, Ontario, CA, received a WARNING LETTER from FDA for violations of the adulteration provisions in sections 402(a) and 501(a) of the FFDCA. Specifically, Mr. Dussen sold a dairy cow for slaughter as human food that was found to contain residues of the drug, Banamine (flunixin meglumine) in the liver tissue at 0.852 ppm. A tolerance of 0.125 ppm has been established for residues of this drug in the liver of cattle (21 CFR 556.286), and therefore, the animal was adulterated under section 402(a). In addition, Mr. Dussen was cited in the WARNING LETTER for failure to use Banamine in conformance with its approved labeling in violation of section 501(a) of the FFDCA. The drug was also used extralabel in violation of section 512(a) of the FFDCA, because such use was not done under the supervision of a licensed veterinarian. Adequate treatment records were also found to be lacking.

Violations of section 501(a) and 512(a) of the FFDCA are the bases for the issuance of a WARNING LETTER to Ben J. Weaver of Clymer, NY. An inspection of his veal calf- raising operation revealed that the new animal drug, Duo Pen (Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension), was adulterated because it was not used in conformance with the extralabel use parameters set forth in section 501(a), 512(a), and 21 CFR Part 530. The drug was administered contrary to both the approved labeling instructions and those of Mr. Weaver’s veterinarian. In addition, Mr. Weaver adulterated the animal feed that was fed to his veal calves within the meaning of section 501(a) of the FFDCA by adding NeoMed 325 Soluble Powder (Neomycin Sulfate) and Uniprim Power for Horses (Trimethoprim and Sulfadiazine) to Strauss Veal Feed Market Blend milk replacer. The extralabel use of drugs in or on animal feed is specifically prohibited by section 512(a) of the Act and by 21 CFR Part 530.

FDA has issued a WARNING LETTER to Michael Brent Masterson of the Tri Mast Dairy, Lebanon, KY, for violations of the adulteration provisions in sections 402(a) and 501(a) of the FFDCA. Specifically, this dairy consigned a dairy cow for slaughter as food without notifying either the hauler or the auction officials of the medication status of the animal; tissue samples revealed the presence of the drug sulfadimethoxine at 1.36 ppm in the muscle tissue and at 1.82 ppm in the liver tissue. A tolerance of 0.1 ppm of this drug has been established by FDA for residues in the edible tissues of cattle (21 CFR 556.640). FDA’s investigation also revealed that the Tri Mast Dairy administered sulfadimethoxine bolus to treat mastitis in a dairy cow, which is not an approved use of this drug. This extralabel use was not done by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship, and, therefore, was a violation of section 512(a) of the FFDCA and of 21 CFR Part 530.

Mrs. Maria Borges, owner of the J&M Dairy, Artesia, NM, has received a WARNING LETTER from FDA for violations of the adulteration provisions of the FFDCA (sections 402(a) and 5102(a)). An analysis of tissues taken from a dairy cow sold for slaughter as food revealed the presence of the drug penicillin at 0.47 ppm in the kidney tissue and at 0.15 ppm in the liver tissue. A tolerance of 0.05 ppm has been established by FDA for residues of this drug in the edible tissues of cattle (21 CFR 556.510). Tissue samples taken of a second dairy cow sold for slaughter as food revealed the presence of the drug sulfadimethoxine at 0.43 ppm in the muscle tissue and at 0.76 ppm in the liver tissue. FDA has set a tolerance of this drug of 0.1 ppm in the edible tissues of cattle. Therefore, the excess amounts of these two drugs rendered both animals adulterated pursuant to section 402(a) of the FFDCA. In addition, the dairy was cited for violation of the adulteration provisions in section 501(a) of the FFDCA, because both drugs mentioned above were not used in conformance with their approved labeling.

A WARNING LETTER was issued by FDA to Ray and Eric Veldhuis, owner and general manager, respectively, of the Veldhuis North Dairy, Ballico, CA, for violation of section 402(a) of the FFDCA. Tissue samples taken from a dairy cow that was offered for slaughter as food revealed the presence of the drug sulfadimethoxine at 0.35 ppm in the liver and at 0.13 ppm in the muscle tissue. The tolerance for this drug in the edible tissues of cattle has been set by FDA at 0.1 ppm (21 CFR 556.640). The firm was also cited for lacking an adequate system to ensure that animals medicated have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. Food from animals held under such conditions is adulterated within the meaning of section 402(a).

Anthony Richard Van Ryn, partner in the Moreno Valley Dairy, Moreno Valley, CA, was cited in a WARNING LETTER for violating section 402(a) of the FFDCA. Specifically, the firm offered for slaughter as food a dairy cow that was found to have residues of the drug sulfadimethoxine in the liver at 5.36 ppm and in the muscle tissue at 4.38 ppm. A second dairy cow was found to have residues of the same drug in the liver at 6.67 ppm and in the muscle tissue at 8.15 ppm. All of these levels exceeded the tolerance of 0.1 ppm in the edible tissues of cattle set by FDA in 21 CFR 556.640, thus rendering the animals adulterated. FDA’s investigation also found that the firm held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply.

Recalls

A firm-initiated Class I recall is ongoing by United Pet Group, Inc., of Cincinnati, OH, for 143,163 packs of Dingo Brand “Chick’n Jerky” for dogs, cats, and ferrets. The affected products were manufactured by Shanghai Peidi Brand Intl. Co. Ltd., Shanghai, China. The products are being recalled because they have the potential to be contaminated with Salmonella. Distribution was nationwide.

ChemNutra, Inc., of Las Vegas, NV, is carrying out a firm-initiated Class I recall of 972 metric tons of Chinese wheat gluten in 25 kg paper bags. The product, manufactured by a firm in mainland China, was found to contain melamine. Distribution of the product was nationwide.

A Class I firm-initiated recall is ongoing by Del Monte Food, Pittsburgh, PA, for 137,457 cases of jerky sticks and snacks for dogs. The reason for the recall was that wheat gluten used to manufacture the products tested positive for melamine.

Cereal By Products of Mount Prospect, IL, is carrying out a firm-initiated Class I recall of 405,482 lbs. of rice protein powder that was made in China. The rice protein powder, which was distributed in Missouri and Kansas, was found to be contaminated with melamine.

A Class I firm-initiated recall is ongoing by Hills Pet Nutrition, Inc., Topeka, KS, for 11,681 units of Prescription Diet Feline. The product was found to be made with raw material wheat gluten that was contaminated with melamine. The product was distributed nationwide and internationally.

Nestle Purina Petcare Co., St. Louis, MO, is conducting a Class I firm-initiated recall of 418,071 cases of ALPO prime cuts pet foods that were distributed nationwide and in Indonesia. The products were made with wheat gluten that was contaminated with melamine.

A total of 63,049 cases of Ol’ Roy and Happy Tails dog food products are involved in an ongoing firm-initiated Class I recall by Del Monte Foods, Pittsburgh, PA. Wheat gluten used to manufacture these products tested positive for melamine. The products were distributed nationwide.

Sunshine Mills, Inc., Red Bay, AL, is carrying out a firm-initiated Class I recall of 24,398 cases of pet biscuits and treats that were found to contain wheat gluten that was contaminated with melamine. The products were distributed nationwide.

A Class I firm-initiated recall is ongoing by Menu Foods Midwest Corp., Emporia, KS, for approximately 127,700 cases of various cat food products that were distributed nationwide and in Canada. Prompted by reports from FDA of the presence of melamine in cans of cuts and gravy pet food produced in Menu Foods’ Canadian facility, the firm identified a single interplant transfer of the ChemNutra-supplied wheat gluten, shipped from its plant in Emporia, KS, to its plant in Streetsville, Ontario. This wheat gluten was subsequently used in the production of pet food in December 2006 and January 2007.

Menu Foods Midwest Corp., Emporia, KS, is also conducting a firm-initiated Class I recall of 53. 3 million cans or pouches (2,384,722 cases) of “cuts and gravy style” pet foods that had been implicated in illness and deaths of cats. These products were distributed nationwide, and in Canada and Mexico.

American Nutrition, Inc., of Ogden, UT, is conducting a firm-initiated Class I recall of 15,594,120 cans and 111,660 bags of various dog, cat, puppy, and kitten food that was distributed nationwide. The reason for the recall is that the products may be contaminated with melamine, which was contained in the imported rice protein concentrate ingredient.

A total of 155 metric tons of rice protein concentrate is the subject of an ongoing, firm-initiated Class I recall by Wilbur Ellis Company, San Francisco, CA. The product, which was manufactured by Binzhou Futian Biology Technology Co. Ltd., Shandong, China (Mainland), was found by FDA to be contaminated with melamine. Distribution of the product occurred in Utah, Kansas, New York, and Missouri.

J Foods, Inc., of Bern, KS, is conducting a firm-initiated Class I recall of 26,668 lbs. of “Spa Select Chicken and Brown Recipe for Kittens” that was distributed nationwide. The product was made with an ingredient pre-blend which was made using a rice protein concentrate that has been found by the supplier and FDA to contain melamine, an unapproved food ingredient.

A Class I, firm-initiated recall is ongoing by Natural Balance Pet Food, Inc., of Pacoima, CA, involving 305,863 bags of the Venison & Brown Rice Dog Food and 174,378 bags of the Venison & Green Pea Cat Food under the “Dick Van Patten’s” label. The firm’s sample analysis has shown products, which were distributed nationwide and in Canada, contain melamine.

Lortscher Agri Service, Inc., of Bern, KS, has completed a Class I recall of one batch of its preblend made with rice protein concentrate for pet food that contained melamine. Distribution of the recalled product was limited to Kansas.

The Scoular Co. of Minneapolis, MN, is conducting a Class I recall of seven lots of a batch of wheat gluten (308, 644 lbs.) made by Xuzhou Anying Biologic Technology Development Co., LTD., of Peixian, China (Mainland). The reason for the recall is that FDA detected the presence of melamine in certain lots of the wheat gluten. Distribution of the product was limited to Alabama and Nebraska.

Mars Pet Care Co. of Everson, PA, has completed a firm-initiated Class I recall of 1,623 bags of dog food that were distributed in New York, Massachusetts, New Jersey, Connecticut, and Pennsylvania. The recall was undertaken because of a possible contamination with Salmonella.

A Class I firm-initiated recall is ongoing by Castleberry’s Food Company, August, GA, for 114,779 cases of dog food under the Dick Van Patten’s Natural Balance label. The products, which were distributed nationwide, and in Canada, Japan, and South Korea, were possibly contaminated with Clostridium botulinum.

A total of 18,000 lbs. of frozen chicken and turkey dog and cat food products are involved in an ongoing firm-initiated Class I recall by BRAVO!! LLC, Vernon, CT. The products are being recalled because of contamination with Salmonella and/or Listeria monocytogenes.

Nutra Blend LLC, Neosho, MO, has completed a Class II recall of 86,700 lbs. of its 50-lb. premix products, including Diamond Pet SG PMX #1, Diamond Pet SG PMX #2, Diamond Holistic Premix, and Kirkland Holistic Premix. The products were recalled because some of the raw material dehydrated parsley powder used in the manufacture of the premixes was found to contain Salmonella. Distribution was limited to Missouri, South Carolina, and California.

A Class III recall has been completed by Kent Feeds, Inc., of Muscatine, IA, for 4,315 50-lb. bags and 39.46 bulk tons of the following items: (1) Bulk Kent HP Calf Creep LTD 30R Medicated, containing 30 g/ton Monensin (as Monensin Sodium; (2) Kent First Rate Show Goat 20R Medicated, packaged in 50-lb. bags, containing 20 g/ton Monensin; and (3) Kent 16% Goat 20R Medicated, packaged in 50-lb. bags, containing 20 g/ton Monensin. The recall was conducted because labeling on the products lacks expiration dates. Distribution of the products was limited to Missouri and Kansas.

A Class III firm-initiated recall is ongoing by Virbac AH, Inc., of Fort Worth, TX, for 22,752 units ResiPROX Leave-on Conditioner, 8oz.; active ingredient: Pramoxine HCl 1.5%. The product, a topical conditioner for dogs and cats, is contaminated with bacteria. Distribution of the product was nationwide.

A firm-initiated Class III recall is ongoing by Valley Proteins, Inc., of Winchester, PA, Inc., for more than 13 million pounds of 58% Protein Poultry Meal Blend that were suspected of containing melamine. Distribution was limited to Pennsylvania and Delaware.

Menu Foods Midwest Corp. of Emporia, KS, has recalled 194 separate lines of cuts and gravy style and other products potentially cross-contaminated with wheat gluten. A total of 464, 565 cases of food distributed nationwide, in Canada and Mexico were involved in the Class III recall.

A Class III firm-initiated recall is ongoing by Brown’s F M Sons, Inc., of Sinking Spring, PA, for 207 bags of its Squirrel Corn Nuggets in 5 lb. bags. The reason for the recall is that the binding agent that was used (AquaBond) was recalled due to melamine contamination. Distribution was limited to Pennsylvania and Virginia.

Ginger Inc. of Toledo, OH, is carrying out a Class III recall of 1,250 units of various fish feeds under the Ginger, Discovery, and Earl May brand names due to melamine in the products. Distribution was nationwide.

A Class III firm-initiated recall has been completed by SouthFresh Feeds of Demopolis, AL, for 233.9 tons of shrimp feed distributed in Alabama and in the country of Belize. The reason for the recall was that the products were manufactured using an aquatic binder that contained melamine, which is unapproved for use in animal and fish feeds.

A Class III firm-initiated recall is ongoing by Uniscope, Inc., of Johnstown, CO, for 4.9 million pounds of a binding agent that was manufactured after January 2004, was used in animal and fish feeds, and contained melamine. The affected products were distributed both nationwide and internationally.

HBH Enterprises of Springville, UT, is carrying out a Class III recall of 165,740 lbs. of its shrimp pellets that were made from a melamine-containing aquaculture product that were used in a variety of ornamental fish foods. Distribution of the affected products took place nationwide and internationally.

A Class III firm-initiated recall has been completed by ADM Nutrition Alliance, Inc., of Quincy, IL, for 90.65 tons of bulk and 478 50-lb. bags of medicated cattle feed. The reason for the recall was that the binder used in the manufacture of the premixes contained melamine. Distribution of the products took place in South Dakota, Iowa, and Minnesota. The same firm has completed a Class III recall of 18 tons of regular and medicated cattle feed in bulk for the same reason (melamine). Distribution of these products occurred in Nebraska and South Dakota.

Rangen, Inc., of Buhl, ID is carrying out a Class III recall of 10.8 million pounds of various fish feeds that were distributed nationwide. The reason for the recall is that the firm received binder (Aqua Tec II) that was contaminated with melamine from another manufacturer that subsequently used the binder in the manufacture of its finished products. The same company is conducting a Class III recall of Rangen, Inc., fish feed products that were manufactured using an ingredient contaminated with melamine and its analogs. Distribution of the 10.7 million pounds of feed took place in Arkansas, California, Mississippi, Kentucky, Texas, Colorado, Alabama, Virginia, Arizona, Oklahoma, Minnesota, Louisiana, Missouri, and Florida.

More than 1.08 million pounds of shrimp and prawn feed products are involved in a firm-initiated Class III recall by Zeigler Brothers, Inc., of Gardner, PA. The feed ingredient (AquaBond) that was used as a binder in the products, which were distributed nationwide and internationally, contained melamine.

A Class III firm-initiated recall is ongoing by Skretting Company of Canada, Inc., Vancouver, British Columbia, for 727,439 kilograms of non-medicated and medicated fish feeds that were contaminated with melamine. Distribution of the products occurred nationwide.

Royal Canin USA, Inc., St. Charles, MO, is carrying out a firm-initiated Class III recall of approximately 322, 600 bags of various dog and cat foods that were distributed nationwide. The pet foods contain rice protein concentrate of Chinese origin found to be contaminated with cyanuric acid, an unapproved food additive. The same firm is recalling 48,486 bags of pet foods under the KASCO label for the same reason, along with approximately 262,000 bags of various sizes of dog and cat foods under the Royal Canin and Sensible Choice labels that were also distributed nationwide.

Tembec BTLSR, Inc., Toledo, OH, is carrying out a firm-initiated Class III recall of 5,196,060 lbs. of pet foods under the A. MAS and Dresbond labels because the products contain melamine, an unapproved food additive. The products were distributed in Mexico and Ecuador.

Contamination with melamine has also led to a firm-initiated Class III recall by LCP Products, Long Beach, CA, for 75 bags of its Lamb Stock Mix in 50-lb. bags. Distribution of this product was limited to Utah.

Rangen, Inc., of Buhl, ID, has completed a firm-initiated Class III recall of 10.8 million pounds of aquaculture and fish feeds that were distributed nationwide. The firm had received a binder product, Aqua Tec 110, that was contaminated with melamine from another manufacturer and subsequently used in the manufacture of their finished products.