FDA Warns Public of Possible Botulism Risk

New Era Recall Expanded for Canned Green Beans and Garbanzo Beans

The U.S. Food and Drug Administration (FDA) today announced that New Era Canning Company, New Era, Mich., is expanding its product recall because of potential Clostridium botulinum (C. botulinum) contamination to all canned green beans and garbanzo beans distributed by the company nationwide over the last five years. C. botulinum can cause botulism, a serious and sometimes life-threatening condition. The affected cans are large institutional-sized containers, weighing approximately six and a half pounds.

Symptoms of botulism poisoning in humans can begin from 6 hours to 2 weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and muscle weakness that moves progressively down the body, affecting the shoulders first, then descending to the upper arms, lower arms, thighs, and calves. Botulism poisoning also can cause paralysis of the breathing muscles, which can result in death unless assistance with breathing (mechanical ventilation) is provided. Individuals who have these symptoms and who may have recently eaten the products under recall or other food products made with them should seek immediate medical attention.

To date, no illnesses have been reported to the FDA; however, consumers should not consume these products, even if they appear to be normal, because of the potential serious risk to health. Consumers who have the affected products or who have used them in recipes should immediately throw the cans and food away.

New Era took this voluntary action in the interest of public health in accordance with FDA's recall request. The company is taking immediate action to retrieve all inventories of the products throughout the distribution chain, including consumers' homes, nursing homes, schools, warehouses, restaurants, retail stores, health care facilities, and other facilities.

For specific brands and codes of green beans and garbanzo beans that are subject to this recall, consumers and retailers can access this information at the following link: http://www.fda.gov/oc/opacom/hottopics/newera.html. Please note that New Era produces canned products under other brand names and labels. Therefore, the recalled products may not necessarily be labeled with New Era's name. Also, the cans may bear a variety of product codes or no codes at all. Regardless of brand name or label, or the presence or absence of a code, the recalled cans should not be opened or used, and should be disposed of as described below. Consumers who are not sure if a product is subject to the recall should still throw it out as a precaution.

Any food that may contain the recalled canned beans should be disposed of carefully. Even tiny amounts of the C. botulinum toxin can cause serious illness when ingested, inhaled, or absorbed through the eye or a break in the skin. Skin contact should be avoided as much as possible, and hands should be washed immediately after handling the food.

When disposing of these products, double-bag the cans in plastic bags. Make sure the bags are tightly closed, then place in a trash receptacle for non-recyclable trash outside of the home. Restaurants and institutions should ensure that such products are only placed in locked receptacles that are not accessible to the public. Additional instructions for safe disposal may be found at www.cdc.gov/ncidod/dbmd/diseaseinfo/botulism_g.htm . Anyone with questions may call FDA at 1-888-SAFEFOOD.

FDA and the Michigan Department of Agriculture launched a joint investigation of New Era's processing plant. This investigation resulted in the identification of C. botulinum contamination in several lots of canned green beans and one lot of garbanzo beans, the identification of serious food violations, and this expanded recall. Original findings of this investigation resulted in the company voluntarily recalling green beans in December 2007 (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01764.html ), and green beans, Mexican-style chili beans, and dark red kidney beans in January (http://www.fda.gov/oc/po/firmrecalls/newera01_08.html ).

FDA initiated the inspection at New Era, along with inspections of other low acid canned food (LACF) manufacturers, following four cases of botulism in consumers who had consumed canned hot dog chili sauce in the summer of 2007. In light of these botulism cases, FDA increased its inspection efforts to assure that manufacturers of all types of LACF products are adhering to applicable FDA requirements. These actions illustrate the need for companies to operate under adequate preventive control systems.

As part of the ongoing investigation, FDA issued an Order of Need for Emergency Permit to New Era. This order prohibits the manufacture and shipment of the company's low acid canned foods across state lines until they demonstrate to FDA's satisfaction that the products are safe. In addition, the Michigan Department of Agriculture, under its state authority, has embargoed New Era's entire inventory of low acid canned products contained in the company's warehouses in Michigan. As a result, New Era is not currently distributing any products.

Prevention of foodborne illness is a key element of the FDA's new Food Protection Plan , launched November 6, 2007.