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Printable version of letter [127KB PDF]
Department of Health and Human Services
Public Health Service
Food and Drug Administration
College Park, MD 20740
APR -3 2009
Dear Manufacturer:
As you may be aware, an investigation by FDA and the California Department of Public Health (CDPH) of Salmonella species (Salmonella spp.) contamination in pistachios sold by Setton Pistachio of Terra Bella, Inc., is underway. The company has stopped distribution of, and has issued a voluntary recall involving, a substantial quantity of its products. Because the recalled pistachios were used as ingredients in a variety of foods, this recall affects many products. Further, the investigation may lead to additional recalls.
The contamination involves multiple strains of Salmonella. Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the blood stream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis. Individuals who are experiencing these symptoms should contact a doctor immediately or go to an emergency room for evaluation.
This letter is to remind you that FDA's current good manufacturing practice (CGMP) regulations apply to processors of pistachio nuts and pistachio products. The CGMP regulations provide in part as follows:
The circumstances under which food is deemed adulterated are set forth in section 402 of the Federal Food, Drug, and Cosmetic Act (FFDCA), and related prohibitions applicable to adulterated food are contained in section 301 (21 U.S.C. 342 & 331). Consequences for violations of the act include seizure, injunction, and criminal prosecution. See, e.g., sections 301(a) through (c) and section 303(a) of the FFDCA.
FDA intends to work closely with the pistachio industry to help it understand the risk of Salmonella and its regulatory obligations under the laws administered by the agency. Companies may wish to obtain CGMP training from universities, trade associations, or private entities. It is up to companies to evaluate their training needs and decide how best to ensure that they are met. FDA also intends to examine current industry practices to identify and address any practices that may lead to contamination by bacteria of public health significance, and to issue guidance to the industry to provide further information about measures to prevent Salmonella contamination.
Stephen F. Sundlof, D.V.M., Ph.D.
Director
Center for Food Safety and Applied Nutrition
Pistachio Industry Processor List
A&P Growers
26487 North Highway 99
Tulare, CA 93274
Arizona Pistachio Company
3865 N Business Center Drive, Suite 115
Tucson, AZ 85705
Artois Nut Company
P.O. box 219
Artois, CA 95913
Braga Farms
10668 Road 26 1/2
Madera, CA 93637
California Pistachio Orchards
P.O. Box 569
Kettlehman City, CA 93239
Fiddyment Farms
P.O. Box 245/3144 Venture Drive, Suite 500
Lincoln, CA 95648
Keenan Farms, Inc.
P.O.Box 99
Avenal, CA 93204-0099
Monarch Nut Company
786 Road 188
Delano, CA 93215
Nichols Farms
13762 First Ave
Hanford, CA 93230
Paramount Farms
13646 Highway 33
Lost Hills, CA 93249
Pistachio Tree Ranch
7320 U.S. Hwy. 54/70 North
Alamogordo, NM 88310
Primex Farms LLC.
16070 Wildwood Road
Wasco, CA93280
Santa Barbara Pistachio Co.
3380 Highway 33
Ventucopa, CA 93252
Setton Pistachios of Terra Bella, Inc.
P.O. Box 11089
Terra Bella, CA 93270
Addendum – Additional Pistachio Industry Processors
Printable PDF file of addendum [10 KB PDF]
Buchanan Hollow Nut Co.
6510 Minturn Road
LeGrand, CA 95333
Coulture Farms
P.O. Box 569
Kettleman City, CA 93239
J & J Byrne Pistachios
4020 Railroad Avenue
Suite A
Pittsburg, CA 94565
Jeff Curry and Associates
2985 Airport Drive
Madera, CA 93637
Nurses Pistachio Orchard
5565 High Ridge Road
Paso Robles, CA 93446
SAM International
2613 Rembrandt Place
Modesto, CA 95356
Sherman Thomas Ranch
25810 Avenue 11
Madera, CA 93637
Smith &