South Carolina business owner sentenced for illegal sale of turtles

I’ve explored my angst with turtles many times over the past eight years of blogging; and while I’m slowly recovering from the childhood trauma (and barfing) I’m always mildly taken aback whenever someone decides to sell the little turtles, even though the act has been banned since 1975.

Because they make little kids sick.

Steve Maleh, 42, who owns and operates Island Breeze on North Forest Beach Drive, Hilton Head Island, was sentenced in federal court in turtle.kissCharleston by U.S. District Judge Sol Blatt Jr., according to a news release from the U.S. Attorney’s Office.

Maleh, of Plantation, Fla., was arraigned last year in U.S. District Court in Fort Lauderdale, Fla., on a seven-count indictment. The U.S. Food and Drug Administration and Hilton Head Island code enforcement officials investigated complaints the store was providing baby turtles to customers.

The federal government has banned the sale of turtles with shells less than 4 inches long since 1975, in an attempt to prevent exposing people, especially children, to salmonella, which can be regularly found on the turtles, according to the FDA and U.S. Attorney’s Office in Charleston.

Hilton Head code enforcement officers and FDA agents made multiple visits to the store over several years, informing Maleh and his staff that distributing juvenile turtles was illegal. But despite numerous warnings, Maleh continued to distribute the turtles to customers, according to a federal prosecutor.

Hulbert said Island Breeze did not sell the turtles outright, but sold small aquariums for about $20 and included a baby turtle with the purchase. The town and U.S. Attorney’s Office had issued numerous warnings to the business, but it continued the practice, he said.

The U.S. Attorneys Office says Maleh also pretended to be an FDA agent. An owner of a competing Hilton Head business received a letter, purportedly from the FDA, telling him to stop selling juvenile turtles or face fines and prosecution. An investigation revealed Maleh sent the letter, according the U.S. Attorney’s Office.

ARO, your pistachios suck, or so says FDA

A Salmonella outbreak followed by an investigation resulted in this warning letter from the U.S. Food and Drug Administration to ARO Pistachios, Inc. in California.

On May 21-May 24th, 2013, investigators from the Unites States Food and Drug Administration (FDA) conducted an inspection of your pistachio processing facility located at 19570 Avenue 88, Terra Bella, California 93270.

During the inspection, FDA found that your facility has serious violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations render your pistachio products ARO Pistachiosadulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FFD&C Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. Our investigators’ observations were noted on Form FDA-483, Inspectional Observations, which our investigators issued to you at the conclusion of the inspection.

In early 2013 (prior to this inspection), your firm was associated with three Reportable Food Registry (RFR) reports that detailed positive Salmonella findings detected in two shipments of raw pistachios distributed by your firm. During the inspection, environmental samples were collected from various locations within your processing facility and analyzed. The analysis revealed the presence of Salmonella enterica serotype Senftenberg (S. senftenberg) in seventeen (17) subsamples.  Specifically, Pulsed Field Gel Electrophoresis (PFGE) testing determined that a single PFGE pattern of S. senftenberg was present in your facility and that the pattern was present in multiple locations within your facility. The recovery of the same S. senftenberg serotype from multiple locations within your facility is a significant concern because it indicates that the pathogen is a potential resident organism in your facility.  Further, finding Salmonella very near to where food is exposed, including numerous product contact surfaces, indicates a high risk of product contamination. 

In addition, a cluster of salmonellosis infections reported from January through May 2013, were investigated by local, state, and federal public health and regulatory agencies. Epidemiological data from the outbreak investigation coupled with results of FDA inspection findings outlined below, and analyses from product and environmental samples collected from your processing facility indicate that pistachios were the likely source of the Salmonella outbreak. Therefore, we believe that your pistachios were also adulterated within the meaning of Section 402(a)(1) of the FFD&C Act because they contained the pathogenic bacteria Salmonella, a poisonous or deleterious substance that may render a product injurious to health.

FDA found:

a.    An employee in your roasting room was observed repeatedly touching the bottom of shipping boxes that were resting on the floor and then touching roasted, ready-to-eat, pistachios without washing or sanitizing hands.

b.    Maintenance personnel were observed entering and exiting the hand sorting room through a door that opens directly to the outside of the facility. Apparent bird droppings were observed on the floor of the outside areas where maintenance personnel were observed working and entering the hand sorting room. Inside the hand sorting room, two buckets containing floor sweepings of pistachios, dust, and debris, were observed near the hand sorting production lines. During the inspection, you stated that the buckets of floor swept pistachios will be reworked into finished product.  The movement of employees from the outside of the facility (where apparent bird droppings were observed) into the hand sorting room may introduce contaminants into your facility and contaminate finished food, particularly based on your practice of reworking pistachios from the floor.

Is 60 days enough for safety? FDA launching pilot testing program for raw milk cheese

In January, the U.S. Food and Drug Administration will launch a pilot program to sample and test domestic and imported raw milk cheese aged at least 60 days for Salmonella, L. monocytogenes, and E. coli O157:H7. On December 19, members of the American Cheese Society (ACS) Regulatory & Academic Committee attended a conference call held by FDA to share information about the program.

This program will test a new microbiological sampling surveillance model, which should help to fill knowledge gaps on the prevalence of microbiological hazards in commodities raw-milk-cheeseand increase FDA’s understanding of risks, contamination rates, and mitigation strategies.

Along with raw milk cheese, the pilot program will include domestic and imported sprouts and raw almonds.

Sampling will begin in January 2014 (an exact date has not been provided) and will last for approximately 12 months. Sampling may take place at any point in the supply chain for domestic cheeses, including at the cheesemaking plant. For imported cheeses, sampling will occur at locations where the cheese normally enters the U.S.

FDA not sure antimicrobial soaps do anything

Every day, consumers use antibacterial soaps and body washes at home, work, school and in other public settings. Especially because so many consumers use them, the U.S. Food and Drug Administration believes that there should be clearly demonstrated benefits to balance any potential risks.

There currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than antimicrobial.soapwashing with plain soap and water, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.

Moreover, antibacterial soap products contain chemical ingredients, such as triclosan and triclocarban, which may carry unnecessary risks given that their benefits are unproven.

“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Rogers says. There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA.

In light of these data, the agency issued a proposed rule on Dec. 13, 2013 that would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.

FDA: pets deserve safe food too (and it’s a human risk)

Don’t ever underestimate the relationship between people and their pets.

Kids, sure. But pets? Don’t go there.

I had a humbling experience – one of dozens – during a talk I gave about pet food safety years ago in Chicago and was roundly chastised for valuing children more than pets.

The U.S. Food and Drug Administration is getting the same message and moved this week to propose preventive measures to protect all sadie.dog.powellanimal foods from disease-causing bacteria, chemicals and other contaminants.

This includes the food that pet owners give their dogs, cats and other companion animals, and the feed that farmers give their livestock.

Preventive Controls for Food for Animals is the fifth rule that FDA has proposed this year as part of the food-safety framework envisioned by the 2011 FDA Food Safety Modernization Act that focuses on preventing foodborne illnesses.

Daniel McChesney, director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine (CVM), said, “Unlike safeguards already in place to protect human foods, there are currently no regulations governing the safe production of most animal foods. There is no type of hazard analysis. This rule would change all that.”

McChesney notes that human and animal health are intertwined. People can get sick when pet food is contaminated by disease-causing bacteria like Salmonella. When such food is handled by pet owners and placed on kitchen surfaces, the bacteria can spread to foods consumed by their family.

The move comes amidst an on-going mystery which has led to the death of 580 pets, nearly all dogs, since 2007, connected to chicken, duck and sweet potato jerky treats, nearly all of which were imported from China. According to the N.Y. Times, it is not clear if the new regulations could have prevented the deaths because the F.D.A. is not sure yet what the hazard is.

This proposed rule would create regulations that address the manufacturing, processing, packing and holding of animal food. Good sadie.sorenne.car.10manufacturing practices would be established for buildings, facilities and personnel, and would include cleaning and maintenance, pest control, and the personal hygiene of people who work there.

It would also require facilities to have a food safety plan, perform an analysis of potential hazards, and implement controls to minimize those risks. Those controls would have to be monitored and corrected as needed.

The proposed rule has been published in the Federal Register, with a 120-day public-comment period. The rule is filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma.

In one of the most infamous examples of pet food contamination, dogs and cats across the country were sickened and killed in 2007 when melamine, a chemical used to make plastic, was added to pet food ingredients imported from China. McChesney noted that FDA received about 18,000 calls from anxious pet owners at the time.

The requirements proposed in both the animal and import rules are designed to help prevent that from happening again, he says.

Food defense + food safety = food protection

Friend of the blog Michéle Samarya-Timm, with the Somerset County Department of Health (Jersey, represent) has written a new paper that will get food safety types excited, because food protection programs involve not only the safety of the food processing facilities in the food supply chain, but Michele portajohnalso the development and use of effective defense measures against intentional contamination.

Michéle writes in Defending the Food Supply: The Basic Recipe that “the term food defense can be a perplexing concept, especially since it represents protecting the food supply from intentional, criminal, and/or malicious contamination. In practice, food safety and food defense overlap in certain respects, but still can be used in a synergistic fashion to build on existing food protection programs.

“For food defense efforts to be effective, though, some common myths must be dispelled and certain resources shared to lay the groundwork for a culture of overarching food protection at local as well as state and federal levels. Among the most important aspects of an effective food defense strategy are the steps taken to: (a) involve the local level; (b) determine vulnerabilities; (c) integrate federal requirements; (d) locate and/or develop essential resources and training plans; and (e) fund the preceding and other initiatives that might be taken.”

The complete paper is available at http://www.domesticpreparedness.com/Medical_Response/Health_Systems/Defending_the_Food_Supply%3a_The_Basic_Recipe/

In Michéle’s words, “All too often, media reports on stupid, strange or wacky things that are found in food, or showcase idiotic things that employees have done to food. If nothing else, this serves to illustrate how easy it is to intentionally contaminate food products where they are being prepared. Local regulators need to become more actively engaged in integrating food defense into their inspections – especially at resource limited mom and pop type establishments —  and share easy to use and understand educational resources, such as the readily available FDA tools.”

Rhetoric reigns: US farmers question produce safety rules

Fresh produce continues to be the source of too many people barfing. Part of the solution is supposed to more government oversight of fresh produce production in the U.S., part of the Food Safety Modernization Act. But even if money is available to fund the activities, farm groups across the country are registering their disproval.

According to Lancaster Online, the U.S. Food and Drug Administration estimates the new regulations could cost farmers more than $459 cantaloupe.salmonellamillion a year to implement.

But, says the FDA, they would prevent 1.75 million new cases of foodborne illnesses a year, saving $1.04 billion in associated costs.

And while most people at a recent Pennsylvania meeting agreed that food safety is a top priority, they said that when it comes to the proposed produce rule, the “devil is in the details.”

Lee Showalter, food safety manager for Rice Fruit Co. in Gardners, questioned what impact the produce rule would have on fruit growers, who are part of a low-risk industry.

No foodborne illness outbreaks have been attributed to tree fruit, he said.

“There is no difference in the provision when it comes to varying risks between produce,” Showalter said.

Frequent testing of water, which FDA claims is needed because it can carry foodborne illness pathogens, could be costly because many fruit growers depend on multiple water sources for their orchards, he said.

Water treatment also could create problems with applying sprays to control disease and insects, according to Showalter.

Philly.com reports that as the nation’s farmers enter a new growing season two years after 33 people died and 147 people were sickened in 28 states after eating listeria-infested cantaloupe from a Colorado farm, the produce industry has effectively delayed implementation of a law intended to improve food safety.

The United Fresh Produce Association, which describes itself as “industry’s leading trade association committed to driving the growth and success of produce companies and their partners” spearheaded the push for more time to comment on a pair of FDA rules toughening safety standards for farms and processors.

Whenever the federal legislation is enacted, cantaloupe growers can expect super special attention.

GPB News reports that FDA recently put growers and industry groups on notice to expect them.

The FDA’s focus on cantaloupe safety comes after two outbreaks of listeria and salmonella contamination in the last few years made hundreds of people ill and killed dozens.

A new coalition of cantaloupe producers from Georgia, Indiana and North Carolina is one of the industry’s responses to those outbreaks. cantaloupe.washThe group’s leader said it also reflects a desire among producers to improve safety.

 “They felt a need to identify how they could improve and enhance the confidence of the consumer in the cantaloupe product,” said Charles Hall, executive director of the ECGA. “We were seeing a trend of consumption going down somewhat.”

Hall said members of the group agree to undergo an initial food-safety audit — called a Global Food Safety Initiative audit — and then a later unannounced one.

Others argue that if FDA is going to up requirements, then FDA needs to up it’s own game.

For example, as reported in The Packer, Bedner Growers Inc., Delray Beach, Fla., voluntarily recalled 1,610 boxes of fresh green bell peppers because they were potentially contaminated with salmonella.

Bedner harvested and shipped the peppers March 25. They are marked with the lot code 102 on the side of each box, according to an April 26 news release from the company.

No illnesses have been reported in connection with the recall and no other

Bedner officials initiated the recall within hours of receiving notification from the Food and Drug Administration “late on April 25,” the release said.

The FDA told company officials a single sample taken April 4 had tested positive for salmonella. Government officials took the sample before the produce reached a retail outlet, but they did not inform Bedner Growers of the sample test until April 25.

Raw milk cheeses face new 60-day scrutiny in US

William Herkewitz of Science Liner writes that in the United States some raw-milk cheeses are as illegal to buy and sell as Cuban cigars or imported ivory. Their crime? They haven’t been shelved for long enough. By federal law, all cheeses aged less than 60 days — usually soft cheeses like mozzarella or brie — have to be pasteurized (heated for sterility) in order to be sold.

The idea is that at 60 days, the fermentation processes taking place within the cheese will have naturally eradicated any harmful bacteria. raw-milk-cheeseBut the U.S. Food and Drug Administration (FDA) is currently reviewing its restrictions on unpasteurized, raw-milk cheeses, with the intent of elongating this time-period.

“Recent scientific literature has raised doubts about the efficacy of 60-day aging as an alternative to pasteurization,” says Marianna Naum, a policy analyst at the FDA.

Enacted in 1950, the 60-day rule was a compromise between cheese lovers and food safety experts, with the former concerned that pasteurization altered both the flavor and traditional methods of cheese making. But much has changed since 1950.

But recent multi-state fatal food-illness outbreaks of even older unpasteurized cheeses have convinced many food scientists that 60 days may simply not be long enough.

Sequester to reduce FDA food inspections, Powell says, eh?

I had to explain to my mom today what sequestration was.

They had just returned from Boston with my sister’s family, and were wondering why all the flights were delayed.

powell_kids_ge_sweet_corn_cider_00I said, sequestration.

She said, what?

I explained how there was these mandated budget cuts and it was now impacting air traffic controllers, so a lot of flights were delayed.

I may have sounded reasonable because I had just got off the phone with Liz Szabo of USA Today, about the effects of sequestration on the U.S. Food and Drug Administration.

Or not.

Liz writes that FDA is losing $209 million because of the sequester; it will perform about 2,100 fewer food inspections because of the cuts; and consumer advocates worry that less oversight will increase foodborne illness outbreaks.

Guess I’m not a self-proclaimed advocate, cause I told her something different.

“Douglas Powell, a professor of food safety at Kansas State University, said private companies have no reason to slack off on food safety, with sorenne.powell.venice.floridaor without inspections.

“Because companies are legally liable for the safety of their food, they have a strong economic incentive to inspect their own products and prevent outbreaks.

“The government is there to maintain a minimal standard, but they really inspect very little food,” Powell said. “It is in a company’s best interest to take that seriously and not make their customers barf.”

FDA commissioner Margaret Hamburg said Wednesday in an exclusive interview with USA TODAY the agency will conduct fewer food safety inspections this year because of the government sequester.

To which I said, uh-huh.

While consumers may not feel the impact immediately, the loss of $209 million from its budget will force the agency to conduct about 2,100 fewer inspections, an 18% decline compared to last year.

The funding loss, part of the $85 billion in automatic budget cuts that took effect March 1, will also delay the agency’s implementation of the 2011 Food Safety Modernization Act, Hamburg said in an interview with the USA TODAY Editorial Board. “Nobody is more frustrated than we are” that the law isn’t yet in practice, said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.