Steps to Prevent Foodborne Illnesses in Fresh Tomatoes

Information Update
2008-92
June 14, 2008
For immediate release

OTTAWA - Health Canada would like to remind Canadians of the importance of proper handling and preparation of fresh tomatoes in order to prevent foodborne illness.

Tomatoes can be part of a nutritious diet and are a great source of vitamins and minerals, according to Canada's Food Guide. Tomatoes are fruits and are commonly red but can also come in a variety of other colours, such as yellow, pink and purple. Tomatoes are often eaten fresh or used as an ingredient in recipes. Popular types of tomatoes include beefsteak, plum and cherry tomatoes.

How can tomatoes become contaminated?

Fresh field tomatoes and other fruits and vegetables don't naturally contain bacteria that can make you sick.

Since tomatoes are grown close to the ground, the fruit can become contaminated in the field by soil, contaminated water, wild and domestic animals or improperly composted manure. Bacteria may also be transferred during and after harvest from handling, storing and transporting.

Fresh fruit and vegetables, including tomatoes, can also become contaminated with disease-causing bacteria when they come into contact with raw food items such as meat, poultry, seafood and their juices. Such contaminations can happen at the grocery store, in the shopping cart, in the refrigerator or from counters and cutting boards at home.

How do I select tomatoes at the grocery store?

When you buy tomatoes, you should look for any signs of bruising or cuts on the skin, and flesh of the tomato. Because they continue to ripen once they are picked, you should always purchase tomatoes that are firm but not hard.

Storing tomatoes

Store whole tomatoes unwashed and uncovered at room temperature. Make sure that they are stored out of direct sunlight. When the tomatoes are ripe, they should be stored in the refrigerator and should be used within a few days.

Cut tomatoes should always be refrigerated at 4ºC (40ºF) or less and can be kept for up to three days. If the cut or peeled tomatoes have been left out at room temperature for more than two hours, you should throw them away.

Since tomatoes can become contaminated by coming into contact with raw meat, poultry or seafood, be sure to separate raw foods from ready-to-eat foods in the shopping cart at the grocery store, and in the kitchen and refrigerator at home.

Cleaning and preparing tomatoes

You should always wash your hands before handling any fresh produce. Wash your tomatoes under fresh, running water. Make sure you throw out any tomatoes that are bruised or spoiled. Don't soak tomatoes in a sink full of water because the sink can harbour bacteria that can be transferred to the tomatoes.

There is no need to use anything other than water when washing tomatoes. Produce washes may not completely remove or kill bacteria, viruses and parasites. Washing tomatoes under fresh, cool running water gently is as effective, if not more so, as using cleansers.
When you are finished washing your tomatoes, cut out the scar where the stem was, and throw it away.

Foodborne Illness and Symptoms

Foodborne illness or food poisoning happens when a person gets sick from eating foods that are contaminated with microorganisms like bacteria, parasites or viruses. Bacteria most commonly linked to tomato foodborne outbreaks is Salmonella.

The most common symptoms of foodborne illness include:

• Stomach cramps
• Nausea
• Vomiting
• Diarrhea
• Fever

It is estimated that there are as many as 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

What is the Government of Canada doing about the safety of fresh produce?

The Government of Canada and industry work together to help identify best practices that can be used to help prevent contamination of fresh produce throughout the food system, from the field to the store. In addition, inspection and enforcement activities conducted by the Canadian Food Inspection Agency work to ensure that steps taken by producers, manufacturers and importers have been effective and that the foods available to Canadians are safe.

Tags: Health Canada, food safty, foodborne illness, Tomato advisory

FDA Issues a Warning (Cancer Risk) for Regranex—Cream for Leg and Foot Ulcers

Warning for Regranex—Cream for Leg and Foot Ulcers

On June 6, 2008, the Food and Drug Administration (FDA) announced that a boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin). The warning addresses the increased risk of cancer death in patients who use three or more tubes of the product.

Regranex is a topical cream for treating leg and foot ulcers that are not healing in patients with diabetes. A boxed warning on a drug's label calls attention to serious or life-threatening risks.

What is the basis for the revised label?

A study compared cancer incidence and cancer death among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed to the product. Although the study showed no overall increase in cancer incidence among the patients exposed to Regranex, there was a five-fold increased risk of cancer death in the group exposed to three or more tubes of the product.

What is FDA advising in regard to Regranex?

In announcing this label change, FDA cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex. The product is not recommended for patients with known malignancies (cancerous tumors).

FDA urges health care professionals to promptly report serious and unexpected adverse reactions associated with Regranex to FDA's MedWatch reporting program. MedWatch reports may be submitted the following ways:

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
• by faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088

Tags: fda warning, Drug Advisory, Regranex, Leg and Foot Ulcers, Cancer Risk

Collaborative effort by FDA and EMEA expected to yield additional safety data For Drug Safety

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
Collaborative effort by FDA and EMEA expected to yield additional safety data

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

The new biomarkers are KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. For decades, both FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA.

"The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible, and help health care professionals better manage potential kidney damage from drugs."

Woodcock added that such human tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental drugs from being approved. With more sensitive tests for renal toxicity, FDA could approve such drugs because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.

Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products.

Researchers from Merck & Co., Whitehouse Station, N.J., and Novartis AG, Basel, Switzerland, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMEA.

The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process.

The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers.

FDA scientists believe that the seven new tests may provide important advantages over the BUN and creatinine tests. For example, in experiments using rats, the two traditional tests can only detect kidney damage a week after it has begun to occur. The new tests, however, are more sensitive and can detect cellular damage within hours. And while BUN and serum creatinine show that damage has occurred somewhere in the kidneys, the new tests can pinpoint which parts of the kidney have been affected.

The seven new tests were developed and will be carried out initially in rats. These tests were selected because other studies have shown that identical biomarkers are produced in human kidney cells. While the FDA and EMEA will consider these biomarkers in rat studies initially, the PSTC has begun work to further qualify the biomarkers for use in human studies. If successful, the PSTC will present a new biomarker data application to the two agencies to seek acceptance of the human biomarkers.

Link to the Predictive Safety Testing Consortium:
http://c-path.org/PredictiveSafetyTestingConsortium/tabid/219/Default.aspx

Tags: FDA Announcement, Drug Safety, EMEA, European Medicines Agency, biomarkers, KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, Trefoil Factor-3

This Barbeque Season, Be Careful With Your Hamburgers! And Stay Healthy.

Following is an advisory by Health Canada but apply equally well to everyone every where who are planing to have barbecue parties. Please be careful and have a healthy Summer!

OTTAWA - Barbeque season has begun and Health Canada would like to remind Canadians of steps they can take to avoid food borne illness from E. coli bacteria from ground beef.

Eating undercooked ground beef can result in a type of food borne illness commonly called hamburger disease, caused by E. coli bacteria. Symptoms can include severe stomach cramps, vomiting, fever and diarrhea. Hamburger disease can be avoided by handling and cooking raw ground beef carefully.

Before you grill:

• When at the grocery store, be sure to keep raw meat separate from other products. Put packages of raw meat in separate plastic bags to keep meat juices from leaking onto other foods.
• Wash your hands thoroughly before and after handling any raw food, especially raw meat, poultry and seafood.
• Make your hamburger patties thin so that they will easily cook all the way through.
• Keep raw hamburger meat away from other hamburger fixings, such as lettuce, tomato, cheese and condiments.
• Use hot, soapy water to clean all surfaces that come into contact with raw meat.

When you cook:

• Your beef hamburger (fresh or frozen) is done when its internal temperature reaches 71°C (160°F). Recommended internal temperatures for other types of hamburgers may be higher.
• Colour alone is not a reliable indicator that a hamburger is safe to eat. Hamburgers can turn brown before all bacteria are killed, so use a digital food thermometer to be sure.
• To check the temperature of a beef hamburger, take the patty from the grill and insert the digital food thermometer through the side, all the way to the middle of the patty. If you're cooking more than one patty, be sure to check the temperature of all the hamburgers.
• Use clean utensils and plates when removing cooked meats from the grill.
• Remember to wash the thermometer in hot, soapy water between temperature readings.

It is estimated that there are as many as 13 million cases of food-related illnesses in Canada every year. Many of these illnesses could be prevented by following proper food handling and preparation techniques.

Tags: barbeque season, food safty, Health Canada, E. coli bacteria, ground beef, hamburger disease, stomach cramps, vomiting, fever, diarrhea

Be Prepared And Keep Your Food Safe During an Emergency

Be Prepared And Keep Your Food Safe During an Emergency
WASHINGTON, June 5, 2008 - The U.S. Department of Agriculture is providing recommendations to those affected by severe storms and tornadoes in the Mid-Atlantic region. USDA is hopeful that this information will help minimize the potential for foodborne illnesses due to power outages and other problems that are often associated with severe weather events.

"Power outages can occur at any time of the year and it often takes from a few hours to several days for electricity to be restored to residential areas," said USDA Under Secretary for Food Safety Dr. Richard Raymond. "Without electricity or a cold source, foods stored in refrigerators and freezers can become unsafe. Bacteria in food grow rapidly at temperatures between 40 and 140 °F, and if these foods are consumed, people can become very sick."

Steps to follow to prepare for a possible weather emergency:

• Keep an appliance thermometer in the refrigerator and freezer. An appliance thermometer will indicate the temperature in the refrigerator and freezer in case of a power outage and help determine the safety of the food.
• Make sure the freezer is at 0 °F or below and the refrigerator is at 40 °F or below.
• Freeze containers of water for ice to help keep food cold in the freezer, refrigerator or coolers after the power is out.
• Freeze refrigerated items such as leftovers, milk and fresh meat and poultry that you may not need immediately — this helps keep them at a safe temperature longer.
• Plan ahead and know where dry ice and block ice can be purchased.
• Store food on shelves that will be safely out of the way of contaminated water in case of flooding.
• Have coolers on hand to keep refrigerator food cold if the power will be out for more than 4 hours. Purchase or make ice cubes and store in the freezer for use in the refrigerator or in a cooler. Freeze gel packs ahead of time for use in coolers.
• Group food together in the freezer — this helps the food stay cold longer.

Steps to follow after the weather emergency:

• Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature.
• The refrigerator will keep food safely cold for about 4 hours if it is unopened. A full freezer will hold the temperature for approximately 48 hours (24 hours if it is half full) and the door remains closed.
• Discard refrigerated perishable food such as meat, poultry, fish, soft cheeses, milk, eggs, leftovers and deli items after 4 hours without power.
• Food may be safely refrozen if it still contains ice crystals or is at 40 °F or below when checked with a food thermometer.
• Never taste a food to determine its safety!
• Obtain dry or block ice to keep your refrigerator and freezer as cold as possible if the power is going to be out for a prolonged period of time. Fifty pounds of dry ice should hold an 18-cubic-foot full freezer for 2 days.
• If the power has been out for several days, check the temperature of the freezer with an appliance thermometer. If the appliance thermometer reads 40 °F or below, the food is safe to refreeze.
• If a thermometer has not been kept in the freezer, check each package of food to determine its safety. If the food still contains ice crystals, the food is safe.
• Drink only bottled water if flooding has occurred.
• Discard any food that is not in a waterproof container if there is any chance that it has come into contact with flood water. Discard wooden cutting boards, plastic utensils, baby bottle nipples and pacifiers.
• Undamaged, commercially prepared foods in all-metal cans and retort pouches (for example, flexible, shelf-stable juice or seafood pouches) can be saved. Follow the Steps to Salvage All-Metal Cans and Retort Pouches below at the end of this document.
• Thoroughly wash all metal pans, ceramic dishes and utensils that came in contact with flood water with hot soapy water and sanitize by boiling them in clean water or by immersing them for 15 minutes in a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water.
• When in Doubt, Throw it Out!

Steps to Salvage All-Metal Cans and Retort Pouches
Undamaged, commercially prepared foods in all-metal cans and retort pouches (for example, flexible, shelf-stable juice or seafood pouches) can be saved if you do the following:

• Remove the labels, if they are the removable kind, since they can harbor dirt and bacteria.
• Thoroughly wash the cans or retort pouches with soap and water, using hot water if it is available.
• Brush or wipe away any dirt or silt.
• Rinse the cans or retort pouches with water that is safe for drinking, if available, since dirt or residual soap will reduce the effectiveness of chlorine sanitation.
• Then, sanitize them by immersion in one of the two following ways:
  • Place in water and allow the water to come to a boil and continue boiling for 2 minutes, or
  • Place in a freshly made solution consisting of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available) for 15 minutes.
• Air-dry cans or retort pouches for a minimum of 1 hour before opening or storing.
• If the labels were removable, then re-label your cans or retort pouches, including the expiration date (if available), with a marker.
• Food in reconditioned cans or retort pouches should be used as soon as possible, thereafter.
• Any concentrated baby formula in reconditioned, all-metal containers must be diluted with clean, drinking water.

Tags: USDA, food safty, retort pouches, baby formula, chlorine bleach, Freeze gel packs

Salmonellosis Outbreak , Red Tomato Warning By FDA Expanded Nationwide

Red Tomato Warning Expanded Nationwide

We have been reporting about this Tomato scare for a while;
Raw Red Tomatoes Advisory (Do Not Eat!) Extends Nationwide

FDA Warning, New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes, Salmonella Outbreak
Now FDA has expanded the warning nationwide.

The Food and Drug Administration (FDA) is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, raw red Roma, raw red round tomatoes, and products containing these tomatoes.

FDA recommends that consumers not eat these tomatoes unless they have been grown and harvested from states, countries, and territories that have NOT been associated with this outbreak. The list, which will be updated as more information becomes available, can be found at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers.

FDA also recommends that retailers, restaurants, and other food service operators not offer raw red Roma, raw red plum, and raw red round tomatoes unless they are from sources that have not been associated with the outbreak. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made.

The following types of tomatoes are NOT likely to be the source of this outbreak. Consumers should continue to eat

• cherry tomatoes
• grape tomatoes
• tomatoes sold with the vine still attached
• tomatoes grown at home

Since mid-April 2008, there have been at least 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin.

For More Information

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01848.html

Tags: salmonellosis outbreak, FDA Alert, Red Tomato Warning

Transition to CFC-free Ozone-Safe Metered Dose Inhalers

EPA has released a press release regarding the discontinuation of CFC based inhalers. EPA phased out chlorofluorocarbons (CFCs) in 1996, with limited exemptions. One of those exemptions is production and import of CFCs for use in essential use inhalers to treat asthma and chronic obstructive pulmonary disease.
We reported about the initial FDA announcement;
Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.

Transition to CFC-free Metered Dose Inhalers Moves Forward

Release date: 06/06/2008

Contact Information: Cathy Milbourn, (202) 564-4355 / milbourn.cathy@epa.gov

(Washington, D.C. - June 6, 2008) For the 2008 calendar year, EPA has allocated 27.0 metric tons of CFC-114 for the manufacture of epinephrine metered dose inhalers (inhalers). In accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer and the Clean Air Act, EPA phased out chlorofluorocarbons (CFCs) in 1996, with limited exemptions. One of those exemptions is production and import of CFCs for use in essential use inhalers to treat asthma and chronic obstructive pulmonary disease.

Each year, in coordination with the U.S. Food and Drug Administration (FDA), EPA allocates essential use allowances to pharmaceutical companies to manufacture essential use inhalers that use CFCs as a propellant. Essential use allowances permit the production and importation of CFCs after the 1996 phaseout solely for manufacturing essential use inhalers. FDA's determination is based on the amount of CFC inhalers necessary to protect public health.

The transition to CFC-free inhalers is well underway and is part of a larger transition that has affected many other consumer and industrial products and sectors over the last several decades. Since 1996, EPA has significantly reduced the amount of CFCs allocated to pharmaceutical companies to manufacture essential use inhalers. In 1998, EPA allocated 4,365 metric tons, and in 2007, allocated 167.0 metric tons.

An important factor in the transition to CFC-free inhalers - although separate from today's CFC allocation rule – is an upcoming prohibition on the sale and distribution of CFC-propelled inhalers containing albuterol. After Dec. 31, 2008, EPA regulations will prohibit the sale and distribution of CFC-albuterol metered dose inhalers. There are now four albuterol inhalers available propelled by ozone-safe hydrofluoroalkanes (HFAs), rather than CFCs.

To foster coordination and education between patients and health-care providers, on May 30, 2008, FDA issued a public health advisory to alert patients, caregivers, and health care professionals that CFC-propelled albuterol inhalers will not be available after Dec. 31, 2008.

Tags: CFC-free Metered Dose Inhalers, epinephrine, albuterol, HFAs, chlorofluorocarbons, hydrofluoroalkanes, ozone-safe, EPA News, FDA, Meddesktop