Tag Archives: FDA

Preliminary FDA Inspection Report Cites Flaws at Diamond Pet Foods Plant

May 16, 2012 By in News Tags: , , , , , , , Leave a comment

By Mary Rothschild | May 16, 2012

Diamond Pet Foods, the company behind a massive recall of dry dog food due to Salmonella contamination that has sickened at least 16 people, was not taking “all reasonable precautions” to ensure the safety of its product, according to the U.S. Food and Drug Administration inspection report.

The Form 483 report, posted by the FDA late Tuesday afternoon, was the result of a week-long inspection that began April 12 after an outbreak of human Salmonella Infantis infection was traced to contaminated pet food manufactured at the Diamond Pet Foods plant in Gaston, S.C.

The report states that Diamond was using cardboard and duct tape on some of its equipment and that there were damaged paddles on the conveyor. The inspectors also noted that some surfaces at the facility were encrusted with food residues.

FDA inspectors specifically listed these four observations:

OBSERVATION 1

All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.

Specifically, no microbiological analysis is conducted or there is no assurance that incoming animal fat will not introduce pathogens into their production and cause contamination of finished product. Also, the firm’s current sampling procedure for animal digest does (sic) preclude potential for adulteration after sampling and during storage in warehouse. On 4/13/12, an employee was observed touching in-line fat filter and oil with bare hands.

OBSERVATION 2

Failure to provide hand washing and hand sanitizing facilities at each location in the plant where needed.

Specifically, there are no facilities for hand washing or hand sanitizing in the production areas where there is direct contact with exposed finished feed/food.

OBSERVATION 3

Failure to maintain equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.

Specifically, paddles in conveyor (South or Middle conveyor leading to the screeners going to packaging) were observed to have gouges and cuts, which exhibited feed residues. The damage to the paddles may allow for harborage areas for microorganisms and are difficult to clean and sanitize.

OBSERVATION 4

Failure to maintain equipment so as to facilitate cleaning of the equipment.

Specifically, firm utilizes cardboard, duct tape, and other non cleanable surfaces on equipment. These materials were observed to have residues adhering. The foam gaskets around access doors to the bucket elevators were observed in deteriorating condition and exhibited an accumulation of feed residues and dust.

Diamond Pet Foods has said, on its website, that it is audited “regularly by a highly respected independent laboratory for food safety, quality and palatability” and that its products go through 141 ingredient tests and 10 final product quality and safety checks prior to shipment.

Phyllis Entis, who has assiduously monitored the outbreak and the various recalls related to it on her eFoodAlert blog, asked Tuesday, “Can anyone tell me how this company, with its self-proclaimed attention to product quality and safety, managed to miss the ongoing presence of Salmonella Infantis in its finished products for at least four months?”

Entis notes that the oldest batch of food in which a government lab found Salmonella was produced on Jan. 3 and 4, 2012, yet Dec. 9, 2011 was chosen as the earliest production date for recall. “This suggests that the contamination was present somewhere in the production environment for five months without being detected by the company’s quality assurance program,” Entis wrote.

As of May 11, at least 15 people in nine states and one person in Canada had been confirmed infected with Salmonella from contact with the contaminated dry dog food or from contact with a pet that had eaten the tainted product, according to the Centers for Disease Control and Prevention (CDC).

The FDA has not yet revealed how many complaints it has received about pet injuries possibly related to the contaminated food.

Diamond Pet Foods recalled nine brands of dry pet foods manufactured at its Gaston plant between Dec. 9, 2011 and April 7, 2012. Several other companies whose food was also produced in the facility have joined the recall. See eFoodAlert for the most up-to-date information on the recall and product distribution.

The CDC offers the following advice:

- Salmonella germs are transmitted from animals to humans and humans to humans by the fecal oral route. Salmonella germs can be shed in the stool of pets for 4 to 6 weeks after infection. (And infected pets may not have any outward symptoms of illness.)

If your pet is diagnosed with Salmonella infection, please talk to your veterinarian about taking precautions to minimize spread of this germ. A mild bleach solution can be used to clean areas that may be contaminated with Salmonella germs.

- Follow these simple guidelines to prevent getting a Salmonella infection from your pet:

After contact with animal feces (stool), wash your hands well with soap and running water. Wash your hands as directed in the handwashing instructions.

Be sure to wash your hands with soap and running water after handling or feeding your pet. Wash your hands as directed in the handwashing instructions.

Clean up after your pet. If you have a dog, use a plastic bag to pick up the stool, and clean up the stool while on walks or from the yard and dispose of the stool in a tightly sealed plastic bag. If you have a cat, scoop the litter box daily and dispose of the stool in a tightly sealed plastic bag.

Do not share food with your pets.

- If anyone in your household becomes ill with diarrhea and has bloody stools, fever, or diarrhea lasting more than 3 days, he or she should seek medical care. If you believe you or someone you know became ill from contact with a contaminated food, including dry pet food, please contact your county or city health department. Please refer to your state health department website to find more information about how to contact your local health department. Reporting illnesses to your local health department helps them identify potential foodborne disease outbreaks. By investigating foodborne disease outbreaks, public health officials learn about possible problems in food production, distribution and preparation that may cause illness.

- If your pet develops diarrhea or appears sick, contact your veterinarian. Do not feed your pet any more of the recalled products. Dispose of the products immediately.

- You can report illnesses associated with pet food in two ways: (1) call the FDA Consumer Complaint Coordinator in your state, or (2) report electronically through the Safety Reporting Portal. Reports should include product details such as brand name, production code (Example: BDR0105E2XJW), expiration date (Example: Best by 3-APRIL-2013), manufacturer or distributor, and location of purchase. Reports also should include medical information.

- More information regarding How to Report a Pet Food Complaint can be found on the FDA website.

The FDA says the recalled pet food does not need to be tested. “The recalled product should be viewed as contaminated and disposed of properly. FDA already knows that the product is potentially contaminated and a recall is in place,” said Laura Alvey, deputy director, communications staff, the FDA’s Center for Veterinary Medicine, in an email.

Source: Food Safety News

CDC: No Source Confirmed in Salmonella Outbreak That Has Sickened 93 in 20 States – 9 in Illinois

April 5, 2012 By in FDA Recall, FDA Warnings, Food Safety, News, Public Safety Tags: , , , , , , , , Leave a comment

Sushi or sashimi suspected

by Mary Rothschild | Apr 04, 2012
Ninety-three illnesses linked to an outbreak of Salmonella Bareilly have been reported from 19 states and the District of Columbia, the Centers for Disease Control and Prevention confirmed Wednesday, but CDC officials said a specific food has not been identified as the source of the infections.

spicy-tuna-sushi-iphone.jpg

However, many of those infected recalled eating sushi, sashimi or a raw dish such as ceviche, in the days before they became ill, according to the public health agency.
In an investigation report released Wednesday afternoon, the CDC revealed the states reporting illnesses: Alabama (2), Arkansas (1), Connecticut (4), District of Columbia (2), Georgia (4), Illinois (9), Louisiana (2), Maryland (8), Massachusetts (4), Mississippi (1), Missouri (1), New Jersey (6), New York (23), North Carolina (2), Pennsylvania (2), Rhode Island (4), South Carolina (3), Texas (3), Virginia (5) and Wisconsin (8).
The CDC’s message follows an internal U.S. Food and Drug Administration email on the outbreak investigation that was inadvertently circulated beyond the agency. That emailed summary did not list all the affected states.
And although the FDA email said investigators were looking at sushi as a possible source of the illnesses, and singled out spicy tuna roll sushi as “highly suspect,” the CDC said no food item has been conclusively identified.
“On initial interviews, many of the ill persons reported consuming sushi, sashimi or similar foods in a variety of locations in the week before becoming ill,” the CDC stated Wednesday. State health officials are continuing to interview outbreak patients about what they ate, the CDC said.
According to the outbreak report, of 51 outbreak-related patients who provided food histories to public health investigators, 37 (69 percent) recalled eating sushi or sashimi during the week before their symptoms began. That compares with a control survey of healthy individuals in which only 5 percent said they’d eaten sushi, sashimi or ceviche in the 7 days before they were interviewed.
At this time, however, the CDC said it is not advising people to avoid any specific foods or specific restaurants, and will alert the public if additional information becomes available.
According to the CDC, the outbreak-related illnesses were reported from January 28 to March 23, 2012. Those ill range in age from 4 to 78 years old; median age is 31.
Illnesses that occurred after March 4 may not yet be included in the outbreak count because of the lag time — an average of 2 to 3 weeks — between when a person becomes ill and and when the illness is reported to health authorities.
In the effort to figure out where this outbreak started, data collected by the states and the agency’s district offices have focused on 6 restaurant clusters where diners later reported illness. Those clusters are in Texas, Maryland, Rhode Island and Connecticut, and two are in Wisconsin, according to the FDA email, which did not identify specific restaurants.
The traceback efforts to find the source of the contamination, according to the FDA email, include looking at menu items ill diners consumed, ingredients, brands, preparation and suppliers in the cases associated with the restaurant clusters. If the outbreak source is sushi, investigators will be trying to determine what part of the sushi was contaminated.
People who think they have become ill from a contaminated food product should consult their health care provider, the CDC noted. The way to confirm a Salmonella infection is through stool specimen analysis.
Most people infected with Salmonella bacteria develop diarrhea, fever and abdominal cramps at least 12 hours and up to three days after consuming contaminated food, so often the last food they ate is not the food that made them sick.
S. Bareilly is a relatively rare type of Salmonella in the U.S., with some estimates indicating it is responsible for only 1 percent of Salmonella infections.
S. Bareilly has been associated with raw sprout contamination in previous outbreaks. In the UK in 2010, there were 241 cases of Salmonella Bareilly infection in an outbreak linked to bean sprouts germinated from contaminated seeds.

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CDC Outbreak Map
This article was updated to include new information from the CDC.


© Food Safety News

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FDA Denies Petition to Ban BPA in Food and Beverage Containers

March 31, 2012 By in News Tags: , , , , , , , Leave a comment

 

Agency will continue to study and review chemical’s effects

by Helena Bottemiller | Mar 31, 2012

The U.S. Food and Drug Administration on Friday denied a petition seeking to ban bisphenol-A, commonly known as BPA, from food and beverage packaging, but the agency said it continues to support research examining the safety of the chemical.

BPA has been used for decades in a broad range of food and beverage containers, including sippy cups, cans and baby bottles. Though standardized toxicology tests have indicated that the chemical is safe, a growing body of research looking at subtle effects at low levels of exposure to the endocrine disruptor has led the Natonal Toxicology Program at the National Institutes of Health and FDA to conclude that they have “some concern” about the potential effects “on the brain, behavior, and prostate gland in fetuses, infants and young children.”

FDA said that while it was denying a petition by the Natural Resources Defense Council (NRDC) to ban BPA, on the basis that it did not provide sufficient scientific evidence, the agency is continuing to study the issue with the National Institute of Environmental Health Sciences.

“I cannot stress enough that this is not a final safety determination on BPA,” said FDA spokesman Douglas Karas. “This is a decision on the NRDC petition. The FDA denied the NRDC petition because it did not have the scientific data needed for the FDA to change current regulations, which allows the use of BPA in food packaging.”

NRDC scientist Sara Janssen expressed disappointment in the agency’s decision: “BPA is a toxic chemical that has no place in our food supply. We believe FDA made the wrong call,” she said. “The agency has failed to protect our health and safety ­- in the face of scientific studies that continue to raise disturbing questions about the long-term effects of BPA exposures, especially in fetuses, babies and young children.”

FDA and NIEHS are in the middle of a $30 million research initiative attempting to shed light on BPA safety. The agency said it was working on finishing another updated safety review based on the new studies. So far, FDA’s research has found that human infants’ exposure to BPA is between 84 and 92 percent less than previously estimated and that the level of BPA from food that could be passed on by pregnant rodents to their unborn offspring is “so low it could not be measured.”

“Researchers fed pregnant rodents 100 to 1,000 times more BPA than people are exposed to through food, and could not detect the active form of BPA in the fetus eight hours after the mother’s exposure,” said FDA in a brief overview of the latest research. “People of all ages process and rid their bodies of BPA faster than the rodents used as test animals do.”

The FDA had until Saturday to respond to a petition filed by NRDC, according to a court order issued in December 2011. The group petitioned FDA three years ago, requesting that BPA be prohibited in food packaging. The NRDC cited human health concerns, and eventually filed suit to force the agency to respond.

Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research, a conservative think tank, said he believes FDA did the right thing by denying the petition.

“The risk-averse FDA would not have left a product on the market if it were dangerous, as NRDC has been claiming,” said Stier in a statement. “At this point, this issue should be laid to rest. The federal government has spent tens of millions of dollars investing in research on BPA, already one of the most well-studied chemicals on earth, and the FDA has squandered its limited resources on multiple safety assessments, including the one litigated by NRDC.”

The packaging industry response was divided along unsurprising lines.

The North American Metal Packaging Alliance (NAMPA), which represents canned food makers, welcomed the news, while the glass industry expressed disappointment.

NAMPA said that FDA’s decision reiterated that BPA, “at current levels of exposure, is safe for use in food contact applications for people of all ages, including infants and children.”

Lynn Bragg, president of the Glass Packing Institute, pointed out that glass is the only widely used packaging designated “generally recognized as safe, or GRAS, and can help consumers reduce their toxic health concerns.”

In its letter to NRDC, FDA said it appreciated the group’s concern about BPA and added that it takes that concern seriously.

“FDA has determined, as a matter of science and regulatory policy, that the best course of action at this time is to continue our review and study of emerging data on BPA,” read the letter. “FDA is performing, monitoring, and reviewing new studies and data as they become available, and depending on the results, any of these studies or data could influence FDA’s assessment and future regulatory decisions about BPA.”

Many companies, including the Campbell Soup Company, have already discontinued or begun phasing out the use of BPA in their packaging and products.

© Food Safety News

Lead in Lipsticks: Which Brands Are The Worst Offenders?

February 14, 2012 By in FDA, FDA Warnings, News, Personal Safety Tags: , , , , , , , Leave a comment

Red lipsticks. (Mike Kemp for The Washington Post)

A new study from the Food and Drug Administration may have you thinking twice about your morning make-up routine. As The Post’s Dina ElBoghdady reports, four hundred types of lipstick were found to contain lead.

Here is a list of the 10 brands and shades that contain the most lead, according the FDA’s study. A full analysis of all 400 varieties is available here.

1. Maybelline’s Color Sensation in Pink Petal. (Lead content: 7.19 ppm)

2. L’Oreal Colour Riche in Volcanic. (Lead content: 7.00 ppm)

3. NARS Semi-Matte in Red Lizard. (Lead content: 4.93 ppm)

4. Cover Girl Queen Collection Vibrant Hues Color in Ruby Remix (Lead content: 4.92 ppm)

5. NARS Semi-Matte in Funny Face. (Lead content: 4.89)

6. L’Oreal Colour Rich in Tickled Pink. (Lead content: 4.45)

7. L’Oreal Intensely Moisturizing Lipcolor in Heroic. (Lead content: 4.41)

8. Cover Girl Continuous Color in Warm Brick. (Lead content: 4.28)

9. Maybelline Color Sensational in Mauve Me. (Lead content: 4.23)

10. Stargazer lipstick in shade “c.” (Lead content: 4.12)

Is your brand on the list? Will you reconsider what lipstick you wear or how frequently you wear it as a result of the study?

Source: Washington Post- By Sarah Halzack

Q&A: Carbendazim and Orange Juice

January 19, 2012 By in FDA Recall, FDA Warnings, Food Safety, News Tags: , , , , , , , Leave a comment

 

What is the problem?

The Food and Drug Administration (FDA) has received reports that low levels of the chemical carbendazim have been found in some orange juice products that contain imported orange juice concentrates.

Carbendazim is a fungus-killing chemical used in Brazil and some other countries to preserve agricultural crops. Brazil provides about 11 percent of the orange juice in the United States market, and industry reports indicate that carbendazim is being used there because of a problem with black spot, a type of mold that grows on orange trees.

However, use of carbendazim on oranges and in orange juices is illegal in the United States. The Environmental Protection Agency (EPA) has not approved the use of carbendazim as a pesticide on oranges and it is an unlawful pesticide residue under the Federal Food, Drug, and Cosmetic Act.

Should I stop drinking orange juice?

No. FDA believes the levels of carbendazim are so low that there are no public health concerns. The agency bases this conclusion on the preliminary risk assessment conducted by EPA, the agency that evaluates the safety of pesticides.

If FDA identifies a brand of orange juice that presents a public health risk due to levels of carbendazim, the agency will alert the public and take the appropriate next steps to ensure that the product is removed from the market.

How did FDA find out about this?

On Dec. 28, 2011, FDA learned from a juice manufacturer that it had detected low levels of carbendazim in some of its orange juice products and also in some of its competitors’ products. The pesticide was also reported in some Brazilian orange juice concentrate that had not been processed into finished product.

Shortly thereafter, FDA sent a letter to the Juice Products Association–the trade association that represents the fruit and juice products industry–stating that carbendazim is a pesticide that is not approved for use on oranges in the United States and that its residues are not allowed in orange juice. Accordingly, FDA will not permit orange juice products containing measurable levels of carbendazim to continue to enter the country.
However, because of the very low levels reported and EPA’s risk assessment, FDA also stated that requiring a recall or the destruction of orange juice products already on the market is not warranted.

What is FDA doing about this?

-FDA is testing samples of orange juice at various manufacturing facilities to determine if any of these products contain carbendazim and at what levels. If orange juice is found with carbendazim in amounts that may be a health risk, FDA will alert the public and take actions to ensure that the product is removed from the market. At this time, FDA does not believe that the amounts of carbendazim found in orange juice and reported to the agency pose any health risk.

-FDA is collecting and analyzing samples of orange juice products that arrive at U.S. borders from all countries and will not allow any that contain measurable levels of carbendazim to enter the United States. Brazil and Mexico are the top two countries that ship orange juice concentrate to the U.S. and both allow carbendazim use. It’s important to know that more than three-quarters of the orange juice sold in the U.S. is from oranges grown in the United States.

-FDA is working closely with EPA in this matter because EPA evaluates the safety of pesticides and approves them for use in the United States. EPA has not approved carbendazim for use in this country; however, EPA determined that the amount of the chemical reported in certain orange juice products does not pose a health risk.

How can I tell if orange juice is from Brazil?

You can read the food label, which is required to list any foreign countries that produced the orange juice concentrate–whether the juice is frozen concentrated (the water is removed) or reconstituted ready-to-drink (the water is added back in to make it liquid.) Note that many orange juice products contain at least some juice from Brazil but that the levels of carbendazim are so low that they do not pose a safety concern. And, for those products now entering the United States from Brazil and elsewhere, they cannot enter the U.S. if they contain measurable amounts of carbendazim.

Why are we importing all this juice anyway?

Orange juice is very popular in this country and to meet the supply year-round, it is common for U.S. food manufacturers who use orange juice in their products to use both domestic and imported orange juice. And juice made from oranges grown domestically (in this country) may not be available year-round due to hurricanes and other weather events.

Brazil is the main source of orange juice concentrate imported into the U.S; however, no whole oranges are imported from Brazil. While Brazil produces the most orange juice in the world, only about 11 percent of the U.S. orange juice supply comes from Brazil. That juice is generally blended with juice from the U.S. and other countries.

For More Information

FDA Letter to Juice Industry

Orange Juice Products and Carbendazim

Import Alerts Guard Against Unsafe Products

Source: US FDA

FDA Shuts Down Chicago Sandwich Maker

December 24, 2011 By in Food Safety, Jack Benton, News Tags: , , , , , , , Leave a comment

By News Desk | Dec 23, 2011

A Chicago food maker agreed to stop making and distributing its sandwiches after the U.S. Food and Drug Administration filed a complaint in federal court describing chronic sanitation problems and Listeria contamination in its processing facility.

Triple A Services signed a consent decree that not only requires the company to halt production, but also to hire a sanitation expert to eliminate Listeria from its plant.

No illnesses have been reported in connection with the company’s sandwiches, but the government’s complaint describes Triple A’s “history of operating under unsanitary conditions and Listeria monocytogenes in the processing facility,” the FDA said in a news release. The complaint also outlines Triple A’s failure to comply with Current Good Manufacturing Practice and seafood Hazard Analysis and Critical Control Point regulations.

Triple A received warning letters from the FDA on April 20, 2011 and on Nov. 18, 2002 that detail FDA’s critical inspection reports.

“FDA took these aggressive actions because Triple A Services continued to violate current good manufacturing practice regulations and allow for conditions that could affect the health of consumers,” said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs.

© Food Safety News