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04/22. Director of Food Safety – West Coast
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04/20. Quality Control Technicians - Lytton, IA
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04/18. Quality Assurance Specialist – Frisco, TX
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04/18. QA and Training Specialist – Florida

04/25 2016 ISSUE:701

Polyethylene Terephthalate: The Safety of Bottled Water
Source :
By Jill Culora
Bottled water’s popularity is at an all-time high–the category is expected to outsell soda by the end of 2016–yet anticorporate adversaries are persistent in their push to create confusion, using online content generators and social media, about the safety of this popular, healthful and convenient consumer product.
Most people consider bottled water to be a safe and healthy alternative to other packaged beverages. And recent polling indicates a vast majority of consumers believe access to safe drinking water in the form of bottled water is important. Confusion about facts can arise when, for example, a friend makes a social media post that is counter to what you know to be true about a product you enjoy. Just Google “bottled water” and “facts” and you’ll see what we mean–a litany of false and misleading reasons to stop drinking the product. The most frequent topic raised is the fallacy that bottled water is not safe. This argument, unsupported by facts, raises alarm by citing flawed studies that make claims about contaminants, questionable water sources and polyethylene terephthalate (PET) packaging leaching chemicals. People spread this scaremongering news without giving it much thought. However, if you take the time to look into these claims, you discover that they just don’t add up. Below are common questions that bottled water manufacturers regularly answer to help reassure customers of the safety of their products.
Is bottled water safer than tap water? 
    Yes, it certainly can be and here is why: Both tap water and bottled water are federally regulated. Bottled water is comprehensively regulated by the U.S. Food and Drug Administration (FDA). By federal law, FDA regulations governing the safety and quality of bottled water must be at least as stringent as U.S. Environmental Protection Agency (EPA) standards for tap water. And in some very important cases, bottled water regulations are substantially more stringent. When compared directly with each other, bottled water provides consumers with a far safer and reliable source of hydration. A Drinking Water Research Foundation (DWRF) study[1] examined and compared the microbial health risks of tap water and bottled water, specifically examining differences in quality monitoring, regulatory standards violations, advisories and distribution system conditions. This study found that as a consequence of the differences in regulations, distribution systems, operating (manufacturing) practices and microbial standards of quality, public drinking water supplies present a substantially higher human risk than do bottled waters for illness due to waterborne organisms. In fact, the U.S. Centers for Disease Control and Prevention directly attributes 19.5 million annual cases of acute gastroenteritis (vomiting and diarrhea) to tap water. Meanwhile, bottled water, which is factory-tested and sealed for safety, has been blamed for just five illnesses in the past 10 years. On a gallon-for-gallon basis, bottled water is tested up to 30 times more frequently than tap water. Another difference is that tap water test results can be averaged over an entire year and still meet EPA standards, whereas every single bottled water result must meet FDA guidelines. The DWRF study also shows a side-by-side comparison of FDA bottled water regulations and EPA tap water regulations to help people better understand how the two are regulated.
Does bottled water contain contaminants?
Bottled water opponents have mischaracterized substances found in bottled water as “contaminants” or “pollutants;” however, this is not the case. For example, fluoride has sometimes been described as a toxic pollutant. In fact, fluoride can prevent tooth decay; the American Dental Association has stated that “More than 70 years of scientific research has consistently shown that an optimal level of fluoride in community water is safe and effective in preventing tooth decay by at least 25 percent in both children and adults.”[2] The levels of added fluoride found in some bottled water brands are in compliance with applicable FDA standards, which the agency updated in 2015, setting the new limit for added fluoride at a maximum of 0.7 mg/L. Another example is heterotrophic plate count (HPC) bacteria, which unscrupulous blog writers rarely fact-check. HPC bacteria are naturally occurring microbes, which are found in a wide array of food products including bottled water. Most bacteria are not harmful, and HPC organisms serve to prevent the growth of opportunistic pathogens because they have the strength to help overcome harmful bacteria and pathogens that may pose a health threat. In the absence of pathogen indicators, such as Escherichia coli, HPC organisms are also considered to be nonpathogenic. There has never been a documented illness associated with HPC bacteria. Neither EPA nor FDA believes there is a health risk associated with background flora in drinking water, including bottled water, and neither agency has set a standard for the amount in drinking water. And another common mistake is to label “total dissolved solids” as “pollutants.” Total dissolved solids, composed of dissolved minerals in water, are important for the taste and character of all waters, including spring water and artesian water, and in the case of mineral water, FDA has set a minimum level of 250 parts per million for these products. 
Isn’t most bottled water just tap water in a bottle?
Many different types of water are used for bottling: artesian, mineral, sparkling, spring and purified. FDA has strict guidelines for identifying and handling each type of water. Purified water is typically sourced from municipal water systems and is not just tap water in a bottle. Once this water enters the bottled water plant, several processes are employed to ensure that it meets FDA’s purified water standard. These treatments may include one or more of the following: reverse osmosis, distillation, microfiltration, carbon filtration, ozonation and ultraviolet (UV) light. The finished water product is then bottled under sanitary conditions and sold to the consumer. Many bottled water drinkers say they prefer a certain type of bottled water because of the taste. Bottled water brands are required to show on their on labels what type of water is used.
Does the PET plastic packaging leach chemicals into the water?
Single-serve bottled water containers are packaged in PET plastic. There are no chemical phthalates or bisphenol A (BPA) in PET plastic, and therefore PET plastic does not leach these substances. PET plastic is approved as safe for food and beverage contact by FDA and similar regulatory agencies throughout the world, and has been for more than 30 years. PET plastic is used in a variety of packaging for many foods, including everything from peanut butter, soft drinks and juices to beer, wine and spirits. Although BPA is not a chemical component of PET, the consensus among international regulatory agencies is that BPA is safe, and regulatory agencies in several countries and FDA have ruled favorably on the safety of BPA.
What about when the bottles are exposed to high or freezing temperatures?
It’s important to understand that single-serve PET plastic bottles do not contain compounds capable of producing dangerous substances under conditions of normal use, including being subjected to hot cars or placed in a freezer. The Johns Hopkins Bloomberg School of Public Health has weighed in on the issue of freezing bottled water. Its website states: “This is an urban legend. Freezing actually works against the release of chemicals…[freezing] would limit chemical release if there were dioxins in plastic, and we don’t think there are.”[3]
Does bottled water cause cavities?
People have many sources of fluoride, and the amount of fluoride exposure varies greatly by community and individual. Approximately two-thirds of communities in the United States fluoridate their public drinking water supplies. Those who live in communities that do not fluoridate public drinking water, who get their drinking water from wells or who filter their fluoridated tap water will not be getting fluoride in their drinking water. Fluoride is present in many foods and beverages, and almost all toothpaste contains fluoride. Too much exposure to fluoride can lead to a condition called fluorosis, which results in stains to the teeth. Consumers should therefore look at how much fluoride they are receiving as part of an overall diet and should contact their healthcare or dental-care provider for their recommendation. For those who want fluoride in their drinking water and wish to choose bottled water, the International Bottled Water Association (IBWA) has about 20 member companies that make clearly labeled, fluoridated, bottled water products under stringent FDA guidelines. For a complete list of these brands, which are available in many markets across the country, please visit the IBWA’s website for more information.[4]
Can restricted access to bottled water affect my health and safety?
Research shows that when bottled water is not available, people choose other packaged beverages, which may contain sugar, caffeine and other additives. A new study, published in the American Journal of Public Health in July 2015,5 concluded that the bottled water sales ban at the University of Vermont resulted in a significant increase (25%) in the consumption of sugary drinks and an increase (8.5%) in the amount of plastic bottles entering the waste stream. The data showed that per capita shipments of bottles, calories, sugars and added sugars increased significantly when bottled water was removed. Shipments of healthy beverages declined significantly, whereas shipments of less-healthy beverages increased significantly. As bottled water sales dropped to zero, sales of sugar-free beverages and sugar-sweetened beverages increased. The purpose of the bottled water sales ban was to encourage students to carry reusable water bottles that could be filled with tap water. That did not happen. The study found that the increase in sugar-sweetened beverage consumption occurred even with the university’s efforts to encourage water fountain use—retrofitting 68 water fountains so that reusable water bottles could be used, introducing educational campaigns to inform consumers about the change and handing out free, reusable water bottles at campus events. This outcome is especially important to highlight since the National Park Service (NPS) has been allowing individual parks to ban the sale of bottled water but not other less-healthy drinks also packaged in plastic–soft drinks, sports drinks, juice drinks and other sugary packaged beverages. IBWA opposes this policy because it denies park visitors the simple option of buying the healthiest packaged drink on the shelf, while at the same time making readily available a broad selection of unhealthy drinks packaged in heavier plastic bottles, which use more water to make. The NPS bottled water sales ban has the potential to undermine efforts to encourage healthy food and beverage choices.
Are bottled water companies using up all of our water?
Bottled water companies support comprehensive water resource management that regulates both the quality and quantity of groundwater, treats all users equitably, provides for the sustainability of the resource and balances the interests and rights of those using this natural resource today and in the future. Environmental stewardship is part of the bottled water industry’s history, and protecting, maintaining and preserving water resources for future generations is taken very seriously. Even though the bottled water industry’s water footprint is a small one relative to overall groundwater withdrawals–the entire United States bottled water industry accounts for less than 0.011 percent of the total ground- or surface water used each year–it continues to focus on improving efficiencies.
If bottled water is so healthy, why isn’t it on the USDA’s “MyPlate” guide?
That’s a good question. The bottled water industry is actively pushing for the addition of water on the U.S. Department of Agriculture (USDA)’s MyPlate graphic. Water, including bottled water, helps people pursue a healthy lifestyle and avoid sugar-sweetened beverage consumption. Water plays a vital role in supporting nutritional health; since 47 percent of added sugars in our diets, and 20 percent of our daily caloric intake, come from beverages, it is clear that Americans need guidance on how to be more aware of what they drink and to reduce their calorie consumption from beverages.
The U.S. is an on-the-go society, and 70 percent of what people drink comes in a package. Research shows that when bottled water isn’t available, many consumers will instead choose a sweetened beverage. Beverage choice often depends on convenience, and therefore consumption of free water is not always a practical choice for consumers. In cases where free tap water is not available, consumers should be encouraged to reach for bottled water instead of less-healthy packaged beverages. The IBWA is recommending enhanced messaging on water consumption in future dietary guidelines, including language that promotes drinking water in all forms. In addition, related information and documents, such as MyPlate, should also promote water consumption.
How much of what we read about the safety of plastic bottled water containers is factual or just a modern-day urban myth?
A large percentage of bottled water is packaged in plastic containers, which includes those made from PET, polycarbonate and high-density polyethylene. Although aluminum cans and glass containers remain popular, most single-serve beverages, including bottled water, sold in the U.S. today are bottled in 100 percent recyclable PET plastic. (Aluminum cans are the multipack leader.) Plastic is popular for beverage containers because it is lightweight, strong and extensively tested for safety; it has been around for more than 100 years and has revolutionized the way we live.
The scientific testing of all plastic containers looks at two specific aspects: establishing that there is a minimal amount of transfer of substance between plastic food packaging and its contents, and establishing that any substances that may transfer from the plastic to the food do not pose a risk to human health.
How does one verify safe packaging?
FDA carefully reviews all packaging substances that come into contact with food and beverages. As part of its review, FDA assesses the migration or potential migration of plastics and substances within plastic into the liquid contents. FDA has found that the levels of migration to food of the substances in plastics are well within the margin of safety based on information available to the agency (i.e., toxicological testing has demonstrated that the cumulative dietary concentrations of these migrants resulting from the use of the plastic materials in food packaging is at least 100- to 1,000-fold lower than the level at which no toxic effect was observed in animal studies). This means no short- or long-term health effects are likely to occur, even from lifelong, daily dietary exposure to these substances migrating from plastic food contact materials.
What is the safety record of polycarbonate plastics?
Media stories have raised questions about the safety of polycarbonate plastic bottles due to the presence of a substance known as BPA. Polycarbonate plastic is used in a wide variety of consumer products, including food and drink containers. Many 3- and 5-gallon bottled water containers are made of polycarbonate plastic, and consumers can remain confident about the safety of these products.
Polycarbonate plastic has been the material of choice for food and beverage product containers for nearly 50 years because it is lightweight, highly shatter-resistant and transparent. During that time, many studies have been conducted to assess the potential for trace levels of BPA to migrate from polycarbonate bottles into foods or beverages. The conclusions from those studies and comprehensive safety evaluations by government bodies worldwide are that polycarbonate bottles are safe for consumer use.
What is FDA’s stance on BPA?
On December 5, 2014, FDA updated its BPA Perspective web page to state that: “FDA’s current perspective, based on its most recent safety assessment, is that BPA is safe at the current levels occurring in foods. Based on FDA’s ongoing safety review of scientific evidence, the available information continues to support the safety of BPA for the currently approved uses in food containers and packaging.”[6]
Do plastic water bottles have a “shelf life?”
Container producers and bottlers continually conduct shelf tests of finished products over varying periods and under various conditions to help ensure the safety and integrity of the package and its contents. Bottled water is considered a shelf-stable product, and there is no information linking safety concerns with bottled water sold up to 2 years after bottling. Some large retailers require all food suppliers (including manufacturers of bottled water and other beverages) to carry a 2-year expiration date. Production-date coding is popular with retailers for stock-rotation purposes.
FDA, which regulates bottled water as a packaged food product, has not established a shelf life for bottled water. IBWA advises consumers to store bottled water (and all other beverages in plastic containers) at room temperature (or cooler), out of direct sunlight and away from solvents and chemicals such as gasoline, paint thinner, household cleaners and dry-cleaning chemicals. In terms of storage and handling, consumers should treat bottled water with the same care and respect as other packaged foods and beverages.
What happens to plastic food containers that are stored in sunlight?
Plastic food containers, including those used for bottled water, do not include additives to prevent the effects of UV light. Those effects may be seen in products such as plastic outdoor furniture, which when left outdoors in the sun may eventually turn color or become brittle. Many plastics used outdoors may contain additives (so-called UV stabilizers) to at least slow down this process, but plastic beverage bottles do not contain such additives, and, as a result, the plastic may become weakened and develop leaks over time. The guidance on direct sunlight is based on general properties of plastics rather than anything specific to the package contents.
What conclusions can be drawn from these facts?
Misleading statements about plastic containers are all too commonly repeated, not only on the Internet but also within our communities. But with all these facts in hand, beverage and food manufacturers are better equipped to deal with their customers’ concerns and can confidently reassure them that plastic is a safe food contact material that has been thoroughly and exhaustively investigated by FDA and several international organizations.  
Jill Culora is a freelance writer, specializing in health, science and consumer news, and is a media consultant to the International Bottled Water Association.

New food safety law gives states big role
Source :
By Michael Ollove, (Apr 24, 2016)
Program aims to prevent outbreaks, rather than fight illnesses
WASHINGTON — With the most extensive food safety regulations in history set to take effect soon, state agriculture officials across the country are preparing to enforce the federal law. But say their ability to inspect farms and enforce the new standards depends on the receipt of promised federal funds.
The law — which Congress approved in 2011 following several high-profile outbreaks of foodborne illnesses, linked to contaminated spinach, tomatoes and peanut products — comes at a time when demand for fresh vegetables is increasing.
And it marks a shift in focus for the nation’s food safety system, from containing foodborne illnesses once they occur to preventing those outbreaks in the first place.
It gives the U.S. Food and Drug Administration new authority to regulate the production of fresh fruit and vegetables. It also imposes the same food safety standards on imports as it does on domestic foods, and includes provisions to create a more integrated food safety system across all levels of government — federal, state and local.
The FDA in February awarded Iowa State University a $950,000, three-year grant to set up a North Central Regional Center for Food Safety Training, making it one of four such centers. Its aim will be offer guidance for growers and processors of food in 12 Midwestern states.
The center will focus on helping smaller-scale operations, ISU officials said last month.
The law, known as the FDA Food Safety Modernization Act and set to take effect gradually through 2020, applies to all farms except meat, poultry and egg producers. Farms that have less than $500,000 in annual sales are not covered, although their buyers may insist that they adhere to the same standards.
And the FDA reserves a key role for states in ensuring that farmers comply with new standards for water quality, sanitation, the handling and composition of compost, and worker training and hygiene. That means on-site inspections and laboratory testing water used in irrigation and soil used in planting.
“State agriculture and public health personnel are the ones who have built relationships with and knowledge of local farming communities and practices and can often deliver oversight most efficiently,” top FDA officials wrote last month.
“But almost all states will have to build produce safety programs largely or completely from scratch. We want to rely on them, not only to deliver education and technical assistance, but also to provide ongoing compliance support and oversight.”
Several states that produce little of the fresh fruit and vegetables covered by the law — states such as Montana, North Dakota and Wyoming — are expected to opt out, leaving that work to federal authorities. But Bob Ehart, a senior policy and science adviser of the National Association of State Departments of Agriculture (NASDA), which has worked closely with the FDA, said that most states, particularly those with extensive food production, seem likely to work with the federal government to carry out the law.
The largest producers of fruits and vegetables are California, Florida and Washington.
Under the law, the federal government is to pay for those new state activities. Several state agriculture departments say it’s too soon to know how much it will cost them.
But many are now preparing applications to the FDA, seeking a share of the $19 million that Congress set aside in 2016 to help states determine what they need to do to help enforce the law, including adopting new state laws or regulations, and identify the farms that it will cover.
The new food safety push comes as the federal government is encouraging Americans to eat more fresh fruit and vegetables, and consumers are following that advice.
But while the federal government and states have long regulated some areas of food production and handling, such as food processing and animal feed, fresh fruit and vegetable growers have largely been left to their own devices.
Several lethal outbreaks of foodborne illnesses convinced lawmakers in both parties, as well as food industry groups and public health advocacy organizations, that the U.S. food safety system was antiquated and ill-equipped to prevent future outbreaks, the NASDA’s Ehart said.
“There was a recognition that we needed to be preventive. We need people to produce food, but we need them to make it safe,” he said.
While most food contamination is thought to occur on farms, it also occurs during transport, packaging and handling by wholesalers and grocers.
The results can be deadly. The Centers for Disease Control and Prevention estimates that 48 million Americans get sick from foodborne illnesses every year; 128,000 of them require hospitalization; and 3,000 die.
The annual cost of those foodborne illnesses is $15.5 billion, according to an estimate by the U.S. Department of Agriculture.
States that choose to participate must decide exactly what role they wish to play, which could include training farmers in the new law and conducting on-site inspections and laboratory testing, as well as determining which state agencies should have responsibility for that work. They must also enact laws or write policies that authorize that role and enable the state to apply for or spend the federal funds. And they must determine which farms in their states are subject to the law, which in turn will determine how many people will be needed to enforce it.
But states have been clear about one thing: “They won’t be doing this work unless the feds provide the resources to do it,” said Katy Coba, director of the Oregon Department of Agriculture. “We don’t have the funds to do this work.”
Joe Reardon, the North Carolina Department of Agriculture assistant commissioner for consumer protection, agreed. He expects many states to increase their own expenditures on food safety, “but it’s equally true that the states have made it clear to the FDA that they will expect additional funding from the federal government.”
Food safety and consumer groups, as well as other organizations, including The Pew Charitable Trusts, have called for full funding of the law. (Pew also funds Stateline.)
President Barack Obama’s 2017 budget calls for another $11 million for the states to begin to implement it. NASDA has asked for more _ $100 million _ and the U.S. House and Senate are considering proposals to increase the contribution to the states. “What we’re hearing from our members is that we can’t implement it until we have federal funding and the day we don’t have the funding we need we will give the whole job back to the FDA,” Ehart said.
For now, Reardon said he thinks most states will work with the federal government on the law. “We anticipate a majority if not all states will adopt laws or regulations with the understanding that there will be adequate funding from the federal government.”
But there may be a few exceptions. “A Montana or Wyoming or North Dakota doesn’t have a lot of produce farms and may think it’s not worth going through the process of setting up (state) laws so they can enforce FSMA,” said Jeff Farrar, the FDA’s director of intergovernmental affairs and partnerships in the office of foods and veterinary medicine. In such cases, the federal government will do inspections and enforcement itself.
The food industry has largely supported the law. “They take a lot of pride in the product they are growing and they don’t want someone to get sick from it,” Coba, the Oregon agriculture director, said.
And “the industry understands they are going to sink or swim by their weakest members,” said Jamie Clover Adams, director of the Michigan Department of Agriculture and Rural Development.
In Michigan, tomato growers saw their sales suffer in 2008 after a bad outbreak of salmonella was traced back to tomatoes grown in the Southwest U.S., Adams said. Similarly, if an outbreak occurs in a particular name brand product _ for instance a brand of peanut butter _ consumers will avoid all peanut butter rather than just that brand, she said.
But large producers were upset that smaller farms were exempted from the law. They also pushed to ensure that food imports face the same standards as those applied domestically.
“Many of the legislators we talked to said one of the reasons they voted for (FSMA) is that it required a level playing field for international growers and domestic growers,” Farrar said.
And the industry has tried to shape the FDA rules that will provide specifics on the law and how it will be enforced, said Roland McReynolds, executive director with Carolina Farm Stewardship Association, a non-profit that represents farmers and food businesses in the Carolinas.
Those rules could, for example, tell farmers how often they need to submit water samples for testing, the type of compounds that can be used to clean workers’ toilets, and what constitutes “adequate” cleanliness.
For farmers, those specifics translate into costs but also choices in what types of crops they choose to grow. “There is a lot of area of concern where rubber meets the road on this,” McReynolds said.

Food safety tips this Earth Day
Source :
By Marissa Harshman (Apr 21, 2016)
Each year, an estimated 133 billion pounds of food in the available food supply goes uneaten.
A new app by the U.S. Department of Agriculture aims to reduce the food loss, impact on the environment and risk of foodborne illness.
The USDA launched the FoodKeeper app last year. The app, which is available on Apple and Android devices, allows users to set up automatic notifications when foods and beverages are nearing the end of their recommended storage date.
FoodKeeper, which can also be accessed online, also provides information about how long food and drinks can be safely stored in the refrigerator, freezer and pantry, as well as cooking tips.
Beef steaks, for example, should be consumed within three to five days when stored in the refrigerator and four to 12 months if frozen, according to the app. The safe minimum temperature for steaks is 145 degrees.
The USDA also offers these refrigerator tips to prevent foodborne illness:
-Keep items in the refrigerator below 40 degrees.
-Over-packed refrigerators do not allow air to properly circulate, meaning some storage zones may not be staying cool enough.
-Keep the front grill of the refrigerator free of dust and lint to allow free airflow to the unit’s condenser.
-Cooked leftovers are safe for three to four days.
-Avoid storing perishables in the door, where temperature changes frequently.
-Drawers are the best storage option for fruits and vegetables.
-Prevent raw meat juices from leaking by storing on a wrapped plate for in a sealed container.

More local food, more food safety risk, more federal grants
Source :
By News Desk (Apr 21, 2016)
With industry reporting that sales of “local foods” more than doubled from 2008 to 2014, concerns about public safety also increased, spurring the U.S. Department of Agriculture to offer almost $5 million in new food safety grants.
The money is to help smaller operations comply with new food safety guidelines established by the Food and Drug Administration under the Food Safety Modernization Act, according to the USDA’s grant announcement.
The smallest operations are specifically exempted from most of the FDA’s new requirements and rules. However, retailers, restaurants and school districts are increasingly demanding that local suppliers meet certain food safety requirements
In addition to small and mid-sized farms, the grant program is intended to help beginning farmers, socially disadvantaged farmers, small processors, small fresh fruit and vegetable merchant wholesalers, food hubs and farmers markets.
As the local food movement has been growing, so has the federal government’s budget for activities described in the USDA’s grant announcement as “providing consumers a stronger connection to their food.”
Since 2009, the USDA has spent more than $1 billion on more than 40,000 local and regional food businesses and infrastructure projects.
“As growing demand for local food creates new economic opportunities for small farms, beginning farmers, and others, we are committed to ensuring that all types of farmers and businesses have the tools they need to be successful,” Agricultural Secretary Tom Vilsack said in the grant announcement Monday.
“By supporting projects that offer tailored training, education, and technical assistance for producers and processors of local food, these grants will benefit producers, the entire food supply chain, and consumers.”
According to the USDA, the grant money is supposed to help smaller operations comply with new food safety guidelines established by the Food and Drug Administration under the Food Safety Modernization Act (FSMA).
However, small operations are specifically exempted from most of the FDA’s new requirements and rules.
The grants are offered through the USDA’s Food Safety Outreach Program and administered by its National Institute of Food and Agriculture (NIFA). Applications are due June 2. See the request for applications on the NIFA website for more information.
Three types of projects are eligible to receive funding through the new grant program:
•Pilot projects will support the development and implementation of new and potentially high-risk, high-impact food safety education and outreach programs in local communities that address the needs of small, specialized audiences from among the various target groups.
•Community outreach projects will focus on the growth and expansion of already-existing food safety education and outreach programs that are currently offered in local communities.
•Multistate education and training projects will support the development and implementation of multi-county, state-wide, or multi-state food safety education and outreach programs where there are common food safety concerns, but the states are not necessarily located within the same regions.


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General Mills expanding food safety footprint
Source :
By Eric Schroeder (Apr 21, 2016)
MINNEAPOLIS — When it comes to expanding its food safety leadership, General Mills, Inc. has set high standards for prevention, quality and investment. The Minneapolis-based company said in its 2016 Global Responsibility Report issued April 13 that it spent $13 million on food safety during 2015.
“Keeping food safe in a global economy poses challenges,” General Mills noted in the report. “Public awareness around food safety increased in the aftermath of high-profile incidents of tainted food, such as peanut butter in the U.S. and baby food in China. While those incidents were unrelated to General Mills, we know that consumers want assurance that the food we provide is safe.”
General Mills has a legacy of food safety leadership, dating back to the 1950s when the company established a raw material vendor management program. In 1980, the company established a food safety regulatory affairs role, and in 1996 it pioneered allergen labeling on all products.
The company continues to emphasize and invest in training focused on sanitation and sanitary design principles. In 2015, the Sanitation Center of Excellence piloted a video training format to reach more people around the world. The video content was translated into four languages to provide more effective, consistent training to all General Mills production facilities.
One of the food safety goals General Mills has set is to achieve Global Food Safety Initiative (GFSI) certification for all General Mills-owned facilities by 2020. Providing an update on the company’s progress toward that goal, General Mills said 72% of its company-owned facilities are GFSI certified. Additionally, 75% of co-production sites and 49% of ingredient supplier sites also are GFSI certified.
“The certification of General Mills’ facilities is an additional assurance that our existing, robust food safety systems continue to evolve and improve,” the company said.
Employee training on food safety issues is a constant for General Mills. During fiscal 2015, the company said it conducted training sessions that were attended by 186 participants from 13 countries.
“These sessions help improve our ability to identify and fix issues, as well as prevent food safety problems from occurring,” General Mills said.
To help ensure the safety of the raw materials the company uses in its products, General Mills has expanded the number of supplier and co-producer audits it conducts globally. The company conducted more than 800 supplier audits and more than 150 co-producer audits in 2015 and trained more than 50 suppliers through supplier schools and webinars during the year.

Food protection group agrees norovirus needs more attention
Source :
By Jim Mann (Apr 21, 2016)
Editor’s note: The Conference for Food Protection is managed by an executive board that includes 23 voting members who represent: state food regulatory agencies from each of the FDA regions; local food regulatory agencies from each of the FDA regions; the FDA; USDA/FSIS; the CDC, the food industry; an academic institution; and consumers.
BOISE, ID — On Wednesday, state representatives arrived and gathered to vote on the work done in recent days by the three Councils of the Conference for Food Protection. They were disadvantaged by not having had participated in the deep-dive assessments, but were briefed by their regulatory colleagues.
The star of the 2016 meeting of the Conference for Food Protection was clearly norovirus. Pre-session chitchat Wednesday continued connecting the many dots between new learning on biofilms and vomit-readiness plans, which should require that a 50-foot diameter area be cordoned off for deep cleaning if norovirus is suspected.
This requirement appears quite important, but will be difficult to implement in places like produce aisles of grocery stores or in quick-serve restaurants where closing a 50-foot circle would mean closing the restaurant. Might the incident be a bout of morning sickness, the flu or too much alcohol? Quick action is a critical part of vomit-readiness plans, offering little opportunity to
Norovirus lexicon was enriched at the 2016 CFP when the word “spewnami” was added as a descriptor for scenes of multiple incidents.
The source dot that carried conversations though to the sixth and final day of the bi-annual meeting was the August 2015 Simi Valley norovirus outbreak among patrons of a Chipotle Mexican Grill restaurant. Conference attendees commented that known shortcomings in food safety controls now threaten executives with personal penal action.
Early last week, just prior to the opening of the 2016 Conference, an exciting norovirus breakthrough was announced by NoroCore. Scientists from Baylor University led a multi-school team to culture human norovirus in the lab, opening the door to many avenues of needed research. This phenomenal advancement is a true display of American scientific prowess. The collaboration adds hope to solving this and many other threats to public health.
Other anecdotal facts were shared at the Conference, each adding new support for the importance of the prime norovirus intervention — handwashing. Aircraft carriers are rarely grouped with the cruise ships but yet they do share in the norovirus war. Military vessels must be battle-ready at all times, but they are totally disabled when this microbial menace hits.
It is difficult to directly connect a Conference issue with new food safety product developments but easy to connect to its idea-generating sidebars. Thanks to one such exchange, researchers have collaborated to develop a norovirus-effective hand sanitizer, now commonly used on cruise liners. Hopefully it will find its way to defend those defending our country.

What China’s food safety challenges mean for consumers, regulators, and the global economy
Source  :
By Lin Fu (Apr 21, 2016)
China’s food safety woes are well-known: Exposés have become all too common, especially after the 2008 scandal over melamine-tainted milk. From gutter oil to fake eggs to contaminated strawberries, the long list of food safety incidents in China means that domestic consumers are understandably worried about the food they can buy and eat. According to a Pew Global Attitudes survey, 71 percent of Chinese people considered food safety to be a big problem in 2015. Improving food safety in China is also important for international consumers because food and ingredients from China can be found on supermarket shelves all over the world.
Addressing food safety concerns can be seen part and parcel of China’s needed transition toward a consumer-oriented economy, which is even more imperative now that the country’s GDP growth is slowing from historic rates. Boosting consumer confidence is an essential piece of that puzzle for China—and by extension, a factor for global economic stability.
Revised law, renewed challenges
China’s revised Food Safety Law, enacted in October 2015, is intended to strengthen the regulation of food companies in China and enhance oversight along the supply chain. Like in other issue areas, however, the challenge is not in setting regulations but in implementing them. The food industry is a difficult one to oversee, and food safety regulators face a wide range of potential hazards—such as absorption of soil contaminants, illegal additives in the production process, and unethical business practices like selling fake or expired items. Chinese food safety regulators must also deal with a still-fragmented (and thus chaotic) domestic food industry. Bringing some semblance of order to the countless farms that supply supermarkets and food processing companies and to the approximately 35,000 food processing companies in China is a governance headache and will take time, but the challenge is not insurmountable.
In fact, policymakers and consumers are already meeting this challenge head-on. China’s State Council has publicly stated that food safety is a top priority and that food producers and local governments will be held accountable if they fail to meet and enforce health and safety standards. The revised Food Safety Law covers more stages along the supply chain and, in direct response to the heartbreaking infant formula scandal, increases requirements governing the infant formula industry. Perhaps most important are the tougher consequences for violators of food safety regulations.
Tightened regulatory oversight and more severe penalties are crucial in the effort to increase consumers’ confidence in the health and safety of their food. Better inter-agency coordination is still needed, however. In addition to the China Food and Drug Administration, the General Administration for Quality Inspection and Quarantine, the Ministry of Agriculture, and the National Health and Family Planning Commission are also involved. Each has its own set of regulations related to food safety, which means that greater coordination and cooperation between the relevant agencies are necessary for the food safety regulatory system to function.
More regulatory requirements and additional inspections along the supply chain will raise the costs of doing business, thereby prompting industry consolidation, which should help make the domestic Chinese food industry more manageable from a regulatory perspective. Some of these additional costs will be passed on to consumers, so it will ultimately be up to them to demonstrate through their purchasing decisions that they are willing to pay more for food that they can trust is safe. The growth of a domestic organic food industry, community-supported agriculture, and white collar farming in peri-urban areas already suggests that there are consumers who are willing to pay more to be assured of the quality of their food supply.
Improving food safety, reducing the trust deficit
Improving food safety has implications beyond public health. Consumer anxiety about food stems as much from distrust of regulatory authorities as it is does from distrust of unscrupulous food producers. Pervasive rumors of government officials having access to special supply farms and widespread anecdotal accounts of farmers keeping separate plots of pesticide-free crops for personal consumption—while regular consumers can only buy food riddled with pesticides—reinforce a sense of distrust and inequality. This, on top of ongoing food safety scandals, contributes to a trust deficit in Chinese society—hence the imperative to improve the situation. Fewer instances of food safety violations and greater supply-chain transparency and product traceability would go a long way toward restoring consumer confidence in the food supply, as well as their trust in producers and regulators. This, in turn, will be essential to China’s efforts to build a robust consumer-oriented economy that can sustain a realistic level of growth—one that supports rather than jeopardizes global economic stability—in the long term.
For more on food safety issues in China, join the John L. Thornton China Center at Brookings for a public event on April 28.

Big strides at forefront of food safety
Source :
By Cai Wenjun (Apr 21, 2016)
SHANGHAI consumes 23 million tons of food every year. Seventy percent of that is sourced from other provinces. Both the large amount and the sourcing of residents' food are a risk for food safety, the Shanghai Food and Drug Administration said.
In order to reduce risks, Shanghai started to work on a monitoring system since 2005.
Since then, the spots being monitored, ranging from supermarkets to wet markets and eateries, have increased from 60 to 500. Food types that undergo regular risk monitoring also rose to 24 types.
Products considered to have higher risks of being unsafe, including rice, flour, edible oil, vegetables, eggs, livestock and poultry meat and dairy products undergo checks every month. The result is regularly released by Shanghai FDA through its website and public media.
Contaminators being tested for also keep expanding, from 72 in 2005 to 427 today. Contaminators like pesticide residue and illegal chemicals in health tonics are being tested for since 2011.
So far, the city’s monitoring system has covered the entire process of farming, production, circulation and restaurants and more than 90 percent of the main supply chain is being monitoring for early and in-time detection of risks, officials said.
For instance, aquatic shellfish is very popular among local residents, but toxins in shellfish can pose a hidden risk to people’s health and can cause acute food poisoning. For those who are allergic, it can even result in death.
Shanghai FDA officials teamed up with environmental protection, oceanology, biology and health experts to set up a shellfish toxin monitoring and alerting system through regular inspection, research and education of the public.
Since bacteria-caused food poisoning is closely related with temperature and humidity, Shanghai FDA started to cooperate with Shanghai Meteorological Bureau to establish an alert system to warn people if there is a medium or high risk of food poisoning under the current weather condition. Alerts are issued through short messages, websites and public media to local food producers and sellers, monitoring departments and consumers.

OSHA finalizes protection for food safety whistleblowers
Source :
By Coral Beach (Apr 20, 2016)
Food company employees — from field workers to grocery store clerks — are on the front lines of food safety efforts but are sometimes reluctant to speak up about problems because they fear retaliation.
A new rule, published Monday in the Federal Register, defines whistleblower protections for employees who disclose information about potential food safety problems.
The final rule from the federal Labor Department’s Occupational Safety and Health Administration (OSHA) fulfills some of the congressional mandates in the Food Safety Modernization Act (FSMA). The Act switches food safety enforcement efforts away from penalties and toward preventive controls.
“Food industry workers must never be silenced by the threat of losing their jobs when their safety or the safety of the public is at stake,” OSHA Director David Michaels said in a news release about the new rule.
“This rule underscores the agency’s commitment to protect the rights of workers who report illegal activity in their workplace.”
The rule establishes procedures for employees who wish to file retaliation complaints and for the government and employers to follow when investigating and responding to such complaints. The rule also explains the burdens of proof, remedies and statute of limitations.
Employees are protected when they “provided or are about to provide to their employer, the federal government, or the attorney general of a state information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of” food safety rules and regulations.
Protections also cover employees who testify or plan to testify about food safety violations, as well as employees who assist in investigations or other proceedings. Employees who refuse to participate in activities that would violate food safety rules are also protected from retaliation.
Employees must file retaliation complaints within 180 days of the alleged retaliatory activity.
“Complaints filed under FSMA need not be in any particular form. They may be either oral or in writing. If the complainant is unable to file the complaint in English, OSHA will accept the complaint in any language,” according to the final rule.
 “… On the basis of information obtained in the investigation, the assistant secretary (of labor) will issue, within 60 days of the filing of a complaint, written findings regarding whether or not there is reasonable cause to believe that the complaint has merit.”
If it is determined that employees are subjected to retaliatory actions, the employees are entitled to a variety of remedies, including reinstatement, back pay and damages for emotional distress and damage to their reputations.

CFP’s sidebars drive food safety in ‘No Action’ atmosphere
Source :
By Jim Mann (Apr 20, 2016)
Editor’s note: The Conference for Food Protection is managed by an executive board that includes 23 voting members who represent: state food regulatory agencies from each of the FDA regions; local food regulatory agencies from each of the FDA regions; the FDA; USDA/FSIS; the CDC, the food industry; an academic institution; and consumers.
BOISE, ID — Robert’s Rules drive order in the complex deliberations at the bi-annual meeting of the Conference for Food Protection. They also drive attendees out of the intense sessions to refresh in open spaces where they can share learning in a spirit of open-mindedness.
Heading into the final day of the meeting today, some frustration was voiced Tuesday by attendees from academia.
“We are invited to join committees because of our scientific knowledge and then the science is ignored, in favor of No Action, protecting the status quo,” one academic said.
“Insufficient science …” was the verdict to warrant a recommendation of No Action for a proposal seen as very important in solving hand cleanliness issues where ready-to-eat produce is harvested.
The proposed protocol — to use hand sanitizers in an unconventional way — was successfully tested by Emory University in a controlled study in produce fields. Dubbed SaniTwice, the method delivered results equal to or better than the soap/water standard.
This second day in Council III of the Conference organization was dominated with similar scenarios with brightly colored stickers announcing “No Action” on a string of agenda items — many of them related to hand washing.
The most frequent sponsors of the No Action option were members of the regulatory community.
Reflections on norovirus precipitated a chorus of disagreement after the Council voted for “No Action” on Issue III-040. ATP (adenosine triphosphate). Using Green Fluorescent Proteins (GFPs), the ATP testing method measures biological cleanliness by showing whether live biological cells are present on surfaces. Live cells are not visible to the human eye and indicate microbial growth.
“This term (ATP) is not used in the FC (Food Code),” was the reason given for the No Action vote on the issue. However, the question before the Council was whether to add a definition for ATP.
The current standard for high-touch, non-food contact surface cleanliness prevailed: “Clean to sight and touch.”
One attendee quipped: “Good news for the covert community of norovirus.”
Pondering progress
With Council work completed today, a well deserved sense of accomplishment prevailed this afternoon in Boise.
Post-Council collaborations are perhaps the strongest element of the Conference for Food Protection. Win or lose, each issue increases awareness and lights a path to future action. The influence of the Conference is undeniable.
A lunch break took some attendees to a nearby restaurant. Guests were welcomed by a greeter while she cleaned menus before handing them to the hungry and appreciative food safety professionals.

China: An Overview of the New Food Safety Law
Source :
By Andrew Sim , Esq., and Yilan Yang, Esq. (Apr 19, 2016)
On April 24, 2015, the Standing Committee of China’s National People’s Congress revised the 2009 Food Safety Law of the People’s Republic of China (Food Safety Law). The revised law came into effect on October 1, 2015.
The revisions to the Food Safety Law are wide-ranging, imposing stricter controls and supervision on food production and management. A review of food safety practices in China is essential to ensure compliance with the new law, limiting potential exposure to regulatory enforcement and subsequent loss in profits.
On December 9, 2015, the China Food and Drug Administration (CFDA) published draft amendments to the Implementing Regulations of the Food Safety Law (Implementing Regulations) for public consultation. The draft Implementing Regulations has provided insights into how the administration intends to implement and enforce the new Food Safety Law, which contains 10 chapters with 154 articles, adding 50 new articles to the old law as well as other revisions.
Highlights of the changes are summarized below.
1. Record-keeping and registration mechanisms for food producers and importers
The primary enforcement powers for food safety used to be divided among different agencies. Since 2013, the State Council has commenced a structural adjustment for the purpose of establishing a more centralized system, with CFDA under the State Council responsible for the supervision of food production, distribution and restaurant/catering services. The centralized system is now explicitly provided under the new law.
Food producers must maintain a record system to record the supply and examination of food ingredients, food additives and food-related products. Such record must be kept for a period of 6 months after the expiration date of the relevant food products, or 2 years if the expiration date is not specified.
Food importers and importing agents must be recorded with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). Manufacturers of imported food products must also be registered with the AQSIQ.
2. Online food platforms
Ordering food online is now a global trend and the safety of food purchased over the internet has raised issues. Under the new law, providers of third-party online food trading platforms must review a trader’s permit and register the real identity of the trader. If a platform provider becomes aware of food safety violations, the provider must immediately stop the trader from such illegal activities and report the same to local FDAs. For serious violations, the provider must immediately stop providing the internet platform service. If a consumer suffers damages from food products purchased through an online trading platform, the consumer can demand damages from the food trader. Where the platform provider cannot provide valid contact information of the food trader, the platform provider will instead be liable to pay the damages.
3. Health foods
Health foods that contain ingredients outside the approved list of health food ingredients must be registered with CFDA. CFDA recordal is required for health foods that are imported for the first time and serve to supplement vitamins, minerals and other nutrients. Other health foods must be recorded with provincial level FDAs. The draft Implementing Regulations have proposed that importation should be conducted within 3 months of the recordal.
Consistent with existing regulations for health foods, the new law prohibits labels and instructions of health foods from referring to any preventive or therapeutic function. They should also contain the statement “this product cannot replace medicine.” Functions and ingredients of the health foods must be consistent with the contents stated on their labels and instructions. The draft Implementing Regulations have proposed that health claims must strictly follow the prescribed index of health food claims, and the language cannot be modified or combined.
To avoid possible public confusion, the draft Implementing Regulations have further proposed that sale areas of health foods be separated from sale areas of pharmaceuticals and other types of food. Under the draft Implementing Regulations, the sales areas of health foods must be clearly identified as such and the statement “this product cannot replace medicine” be prominently displayed.
4. Baby foods
A key revision under the new law is stricter regulation for baby formula food. The ingredients, food additives, formula and labels of baby formula food must be recorded with provincial level FDAs. Formulas for baby milk must be registered with CFDA. Reports and other materials showing the development process and safety of the formula must be submitted for formula registration.
Baby milk formulas that are manufactured overseas and imported to China must not be repackaged for import purposes. For manufacturers of baby milk powder, the same formula cannot be used under different brand names.
5. Genetically modified foods
The new law introduces rules on genetically modified foods and provides that packages of genetically modified foods must be labelled as such, and the information on the labels must be accurate. The draft Implementing Regulations propose that the words “non-genetically modified” cannot be used on genetically modified foods or genetically modified raw materials which have not been approved by the authorities.
6. Foods for special medical purposes
Formula foods for special medical purposes must be registered with CFDA. The product formula, production technology, labels, instructions and materials showing the safety and nutritional adequacy of the product and clinical effects of special medical use must be submitted for product registration. The new law stipulates that relevant regulations for pharmaceutical advertising apply to advertisements of foods for special medical purpose. According to the draft Implementing Regulations, advertisements of food formula providing complete nutrition for specific medical purpose will be regulated as advertisements of prescribed drugs, while advertisements of other types of food formula for special medical purpose will be regulated as advertisements of nonprescribed drugs.
7. Increased sanctions
Compared to its previous version, the new law impose harsher sanctions on food safety violations.
For food traders, engaging in the production of foods or food additives without proper permit will be subject to an administrative fine up to 20 times the products’ value. Likewise, failure to register health foods, formula foods for special medical use or baby milk formulas is subject to an administrative fine up to 20 times the products’ value and the food permit may be revoked in serious cases.
If a party provides a food trader with production or selling facility or other facilitating conditions with the knowledge that the trader is engaged in illegal production of food or food additives, that party will be subject to a fine up to RMB 100,000 and be jointly liable for damages suffered by consumers.
Punitive damages up to 10 times the products’ value are available to consumers where the food products fail to meet food safety standards, except for deficiencies in product labels and instructions if such deficiencies do not mislead consumers.
The new law is claimed to be the strictest food safety law in Chinese history. It shows the proactive attitude of the Chinese government in cracking down on food scandals that have affected the country in recent years, leading to poor consumer confidence in domestic products. CFDA and local FDAs are now granted more enforcement powers in addressing food safety issues.
The new law places more emphasis on the supervision and control of every step of food production, distribution, sale and recall. Special provisions are set out for food products which have been a focus in food safety incidents in recent years, especially health foods and infant milk formulas. Meanwhile, the new law has also taken into account new types of food trading activities, including food sold on a third-party trading platform and food imported through e-commerce channels. With respect to the latter, the draft Implementing Regulations propose that food imported through e-commerce channels are subject to the same regulations as those applicable to food products imported through traditional channels.
The new Food Safety Law is significant for China as its amendments and revisions will improve the quality of food products and instill public confidence in the Chinese food industry. Many of the provisions serve to clarify, consolidate and expand pre-existing food safety restrictions under specific regulations for the relevant product categories, but with more severe penalties. The new law also gears regulatory bodies with more authority, sets harsher penalties for violations and introduces more guidelines for consumer product manufacturing and production.
Andrew Sim, Esq., is a partner and Yilan Yang, Esq., is an associate in the Intellectual Property Practice at Baker & McKenzie in Beijing.

What you need to know about hepatitis A
Source :
By Denis Stearns (Apr 19, 2016)
What is hepatitis A?
Hepatitis A is one of five human hepatitis viruses (hepatitis A, B, C, D, and E) that primarily infect the liver and cause illness. An estimated 80,000 cases occur each year in the U.S., although much higher estimates have been proposed based on mathematical modeling of the past incidence of infection. Each year, an estimated 100 persons die as a result of acute liver failure in the U.S. due to hepatitis A, but the rate of infection has dramatically decreased since the hepatitis A vaccine was licensed and became available in the U.S. in 1995.
Hepatitis A is a communicable (or contagious) disease that spreads from person-to-person. It is spread almost exclusively through fecal-oral contact, generally from person-to-person, or via contaminated food or water. Food contaminated with the virus is the most common vehicle transmitting hepatitis A. The food preparer or cook is the individual most often contaminating the food, although he or she is generally not ill at the time of food preparation. The peak time of infectivity, when the most virus is present in the stool of an infectious individual, is during the two weeks before illness begins. Although only a small percentage of hepatitis A infections are associated with foodborne transmission, foodborne outbreaks have been increasingly implicated as a significant source of hepatitis A infection.
Hepatitis A may also be spread by household contact among families or roommates, sexual contact, ingestion of contaminated water, ingestion of raw or undercooked fruits and vegetables or shellfish (like oysters), and from persons sharing illicit drugs. Children often have asymptomatic or unrecognized infections and can pass the virus through ordinary play to family members and other children and adults.
Symptoms of hepatitis A Infection
Hepatitis A infection may cause no symptoms at all when it is contracted, especially in children. Such individuals will only know they were infected (and have become immune ñ you can only get hepatitis A once) by getting a blood test later in life. The incubation period (from exposure to onset of symptoms) is 15-50 days, with an average of 30 days. Many children and most adults will experience the sudden onset of flu-like symptoms. After a day or two of muscle aches, headache, anorexia (loss of appetite), abdominal discomfort, fever and malaise, jaundice (also termed icterus) sets in. Jaundice is a yellowing of the skin, eyes and mucous membranes that occurs because bile flows poorly through the liver and backs up into the blood. The urine will turn dark with bile and the stool will be light or clay-colored from lack of bile. When jaundice sets in, the initial symptoms begin to subside.
In general, the period of acute illness lasts from 10 days to three weeks, at which time affected individuals tend to recapture some sense of wellness. It is not unusual for blood tests to remain abnormal for six months (or more), prolonging recovery for up to a year. Most affected individuals show complete recovery within three to six months of the onset of illness. Relapse is possible, and although more common in children, it does occur with some regularity in adults.

Barriers go up against shrimp and prawns from Malaysia
Source :
By News Desk (Apr 19, 2016)
American consumers are scooping up more shrimp than ever at lower prices, but it is not all good news because some aquaculture-grown shrimp and prawns from Malaysia contain residues from unapproved animal drugs and unsafe food additives.
The combination of the huge consumer demand in the U.S and the growing potential for unsafe product getting into the country caused the U.S. Food and Drug Administration (FDA) to issue  an import alert yesterday on Malaysian shrimp and prawns.
An import alert means border agents will detain a food product without physical inspection.
Shrimp is among the most popular of the all the imported seafood being consumed in the United States. About 90 percent of the seafood being consumed by Americans is imported from about 140 counties around the globe, according to FDA.
Malaysia is usually among the top 10 suppliers of imported shrimp and prawns to the U.S. And, the expansion of the aquaculture industry there has come with more misuse of animal drugs and unsafe chemicals.
FDA says there is “clear scientific evidence” that these compounds are being used in “various stages of aquaculture” that can result in the presence of residues in the edible portion of the seafood.
There is also the potential for bacteria to be transferred to humans, reducing the effectiveness of antimicrobial drugs for the treatment of human disease. FDA is especially concerned about the potential for antibiotic residues from nitrofuran and chloramphenicol.
According to the National Oceanic and Atmospheric Administration (NOAA), shrimp exports to the U.S. were up in all but one of the top seven supplier nations. NOAA said the exports were up 17.5 percent in February on a year-on-year basis.
The reason would seem to be lower prices, with the average price per kilogram at $8.89, compared to $10.13/kg for February of 2015.
Imports from Indonesia, India, Thailand, Vietnam, China and Mexico — six of the top seven shrimp exporters to the U.S. — all increased. Imports from Ecuador are the only major supplier that were off, down about 11 percent.
The area being targeted by FDA in the April 18 import alert is a seven-state and two federal territory area of the Peninsular Malaysia area. FDA officers will be detaining shrimp and prawns from the area. Shipments from firms that are eligible to be on a “green list” will be accepted.
Detained shipments from Peninsular Malaysia will have to be tested by a private laboratory to show they are clean of the two targeted antibiotics before they can gain entry to the U.S. market.
In a study that ran from Oct. 1, 2014, to Sept. 30, 2015, FDA found the antibiotic residues in 45 samples or about 32 percent of the shrimp and prawns being exported to the U.S. from Peninsular Malaysia.

Contemplating Campylobacter Conundrums
Source :
By Timothy Freier, Ph.D., and Patrick Kennedy
A “conundrum” is defined as “an intricate and difficult problem.” That definition seems perfect for an article discussing Campylobacter. Also, it starts with “c,” and who doesn’t enjoy a good alliteration? Campylobacter spp., particularly thermophilic Campylobacter, have emerged as a leading cause of human foodborne gastroenteritis worldwide, with C. jejuni, C. coli and C. lari reportedly responsible for the majority of human infections (well, maybe; more on this later). Although most cases of campylobacteriosis are self-limiting, this illness represents a significant public health burden. To anyone who has been unlucky enough to experience this illness, the low mortality rate is of little comfort when faced with potentially severe symptoms such as cramping, abdominal pain, fever, nausea and vomiting, and watery, sometimes bloody diarrhea. Perhaps even more important than the gastrointestinal distress, Campylobacter can use a mechanism called molecular mimicry to trigger a very severe autoimmune disease, Guillain-Barré syndrome, which is the most common cause of acute flaccid paralysis. In 2013, U.S. FoodNet data indicated Campylobacter was the second-most common bacterial agent identified in foodborne illness reports (35% of reported infections) following Salmonella (38%).
Campylobacter is also one of the foodborne pathogens that has frustrated public health agencies’ efforts to reduce its contribution to illnesses. The Healthy People 2020 target rate for Campylobacter infections is 8.5 cases per 100,000 people, but the 2014 rate of culture-confirmed infections was reported to be 13.45.[1] There are many interesting conundrums concerning this organism that contribute to its being and continuing to be a leading cause of foodborne illness.
Conundrum #1: Since Campylobacter and Salmonella are both highly associated with poultry, won’t the same interventions being used to control Salmonella also reduce Campylobacter?
The poultry industry has placed the majority of its pathogen-control emphasis on Salmonella. Major outbreaks linked to Salmonella Enteritidis in shell eggs and Salmonella Heidelberg and Hadar in various chicken and turkey products caused the poultry industry and regulatory agencies to declare war on this pathogen in poultry. Campylobacter, although known to be associated with poultry, tends to cause sporadic foodborne illnesses rather than outbreaks; thus, less emphasis has been placed on its control in poultry.
It is well established that Campylobacter is very commonly harbored in the gastrointestinal systems of most domesticated and wild animals. In fact, it has been estimated that greater than 80% of food animals carry Campylobacter.[2] Many of the preharvest interventions used by the egg and poultry industries to control Salmonella have no doubt also had an influence on controlling Campylobacter. For example, protecting poultry from environmental contamination through enhanced biosecurity, litter management and drinking water treatment would be expected to reduce the incidence of both pathogens in live birds. The use of competitive exclusion through the application of probiotics may also reduce the incidence of both pathogens. However, more specific interventions, such as vaccines, bacteriophages and bacteriocins, would need to be targeted specifically to Campylobacter to have an impact. While poultry feed is thought to be a potential source of Salmonella introduction to poultry, it is probably not a source for Campylobacter, as it does not survive well in low-moisture products.
An important question for effective preharvest Campylobacter control is whether transmission of this pathogen is vertical or horizontal. Vertical transmission means that Campylobacter contamination moves from the breeder hen to the egg to the chick. Horizontal transmission is contamination originating from the water, feed or environment. It is well accepted that Salmonella can spread in poultry via vertical transmission, and some serotypes, such as S. Enteritidis, are known to be internalized into the egg. It has been less clear whether this can occur with Campylobacter. Researchers have not been able to demonstrate that internalization of Campylobacter into eggs is a significant factor for transmission. Much work has been done to determine whether viable but nonculturable Campylobacter could be transferred via the egg and then eventually colonize newly hatched chicks, but it has been concluded that this is not a significant occurrence.[3] However, another study showed that when 2,000 chick paper pad tray liners were sampled in commercial chicken hatcheries, 0.75% were positive for Campylobacter, supporting previous findings indicating the potential for Campylobacter to be spread by vertical transmission.[4] While probably not internalized within the egg, Campylobacter can be transmitted via the eggshell. In one study, a total of 2,710 eggs were examined, and viable Campylobacter was found on 4.1% of the eggshell samples while Salmonella was found on 1.1%. In this study, egg yolk samples were negative for both pathogens.[5]
Placing insect screens on poultry houses may be one simple and effective intervention for Campylobacter control. In a study conducted in Denmark, insect screens were placed on some broiler houses and not on others. The houses without the fly screens had a Campylobacter flock-positive rate of 51.4% compared with 15.4% for the houses with the screens.[6] This study was repeated and confirmed with a multiyear study, also conducted in Denmark, which found the prevalence of Campylobacter-positive flocks was significantly reduced, from 41.4% during 2003–2005 (before fly screens) to 10.3% in 2006–2009 (with fly screens). In fly-screen houses, Campylobacter prevalence did not peak during the summer as it did in the houses without screens. Nationally, the prevalence of Campylobacter-positive flocks in Denmark could have been reduced by an estimated 77% during summer had fly screens been part of biosecurity practices.[7]
Postharvest interventions, such as sanitary dressing procedures and the use of antimicrobial solutions during multiple steps of the slaughter and further processing activities, would be expected to reduce the incidence of both Campylobacter and Salmonella. One intervention that has been targeted specifically for Campylobacter reduction is the use of frozen storage. In fact, some countries require the freezing of carcasses originating from more highly contaminated Campylobacter flocks as a public health control intervention.[8] While this practice does appear to have impacted illnesses, other researchers have questioned whether freezing is a truly effective intervention and whether the results may be an artifact of the difficulties in culturing and detecting Campylobacter.[9]
Campylobacter is not typically considered to be a pathogen that can survive or grow in the food manufacturing facility environment. It is rarely, if ever, the focal point of environmental monitoring programs. Investigations of Campylobacter illnesses associated with foods have not indicated that manufacturing facility contamination has been a causative factor. As a difficult and relatively expensive organism to test for, Campylobacter is not an ideal candidate for routine environmental monitoring as a verification of prerequisite programs.
Perhaps the most important consideration for Campylobacter control in the food manufacturing facility environment is the water used for direct product contact or addition to products. Consumption of contaminated drinking water is a significant cause of Campylobacter infections. If it is determined that water testing would be prudent, testing large volumes of water may be required to reach the desired sensitivity for either culture or molecular detection methods, and stressed cells of Campylobacter can be especially difficult to detect.[10] A good practice to reduce this risk is to carefully evaluate all sources of water used in the manufacturing process, being sure to trace and map the entire water system. Water that is used for direct product contact or product addition should have residual chlorine or be otherwise treated to be fit for use.
The U.S. Department of Agriculture (USDA) recently published an updated Draft FSIS [Food Safety Inspection Service] Compliance Guideline for Controlling Salmonella and Campylobacter in Raw Poultry.[11] In this document, the agency offers the following testing recommendations:
“There are no identified index organisms that directly reflect the presence or absence of pathogens in poultry (e.g., Salmonella and Campylobacter). Therefore, FSIS recommends that an establishment test for pathogens at least intermittently and compare its results against the presence or absence of other non-pathogenic organisms (i.e., the indicator organisms the establishment is using) to assess whether it is maintaining process control. The indicator organisms can provide evidence of control, while periodic testing for pathogens may verify that the establishment is reducing pathogens to acceptable levels. Establishments conducting their own ongoing verification sampling of finished product for Salmonella and Campylobacter can use the FSIS performance standards as indicators of process control.”
Due to changes in methodology and sampling programs, it is difficult to use USDA compliance data to prove a parallel reduction in Salmonella and Campylobacter incidence in poultry. However, despite the emphasis on Salmonella control, there does seem to be a generally similar reduction in both pathogens in poultry in the U.S. In the third quarter of 2011, the average prevalence of Salmonella in broiler carcasses was 8.2% and Campylobacter was 8.5%. During the third quarter of 2015, the prevalence of Salmonella and Campylobacter in young chicken carcasses was 1.4% and 2.2%, respectively.[12] These results suggest that while the industry target has mainly been Salmonella, there has also been a concomitant reduction in Campylobacter in U.S. chicken carcasses.
Conundrum #2: Is campylobacteriosis mainly attributed to food, water or other sources?
A review of Campylobacter outbreaks in the U.S. revealed that common vehicles of transmission were food (86%), water (9%) and animal contact (3%). Dairy products were implicated in 29% of the foodborne outbreaks, poultry in 11% and produce in 5%.[13] However, the majority of cases of campylobacteriosis are sporadic, and it is extremely difficult to trace the source of these types of illnesses. It is often generalized that the majority of sporadic cases can be attributed to consuming undercooked poultry or to cross-contamination of ready-to-eat foods with Campylobacter originating from raw poultry, whereas the majority of outbreaks stem from dairy products. However, it seems plausible that nonfood sources may account for an even-greater percentage of the sporadic cases. Besides the extreme epidemiological challenge of attributing the source of sporadic illnesses, there is a challenge in detecting Campylobacter, especially when it is in a stressed condition, as can be expected when trying to isolate the organism from environments such as water or mud. As an example, researchers in Canada found that Campylobacter was frequently detected at low concentrations in a watershed in southern Ontario. When using quantitative PCR, higher prevalence was found compared with a cultural method, probably because of the formation of viable but nonculturable cells. It was concluded that Campylobacter in surface water can be an important vector for human disease transmission and that method selection is important in determining pathogen occurrence in a water environment.[14]
Another interesting phenomenon concerning nonfood sources of campylobacteriosis has been an association with outdoor competitive events. One of the largest reported campylobacteriosis outbreaks in Canada was associated with a mountain bike race that took place in muddy conditions in British Columbia during June 2007. Of the 537 racers included in a follow-up epidemiological study, 225 racers (42%) reported diarrheal illness after the race. C. jejuni clinical isolates (n = 14) were found to be identical by multi-locus sequence typing. Direct accidental ingestion of mud was significantly associated with illness, making mud the most likely source of Campylobacter infection.[15] A similar outbreak occurred during a muddy mountain bike race in the United Kingdom in 2008.[16] An outbreak in Nevada in 2012 was associated with a long-distance obstacle adventure race.[17] These types of outbreaks may represent the tip of the iceberg when extrapolating to sporadic cases and taking into consideration the ubiquitous occurrence of Campylobacter in water, mud and animal feces.
Getting back to the alliterations theme, a very interesting theory explaining a Campylobacter conundrum was put forth in a paper entitled “Flies, Fingers, Fomites, and Food.”[18] The conundrum was that in New Zealand, there is a distinct seasonality of campylobacteriosis, while one of the main food associations is the consumption of cooked chicken at fast-food establishments, a link that did not seem to completely explain the seasonality. The seasonality did, however, correlate quite nicely with the life cycle of flies in the region, with increased illnesses correlating to increased fly foraging activity. The authors postulated that the Campylobacter might be food-associated rather than foodborne, in that the flies might have contaminated fomites such as door handles, and chicken is commonly consumed by handling directly with the fingers that may have contacted the fomites. The contamination may be more a factor of fingers and fomites spreading the contamination from flies directly onto the cooked chicken and into the mouth of the consumer rather than undercooking or cross-contamination in the kitchen, very much changing how this risk can best be mitigated. It should be noted that the New Zealand Food Safety Authority disputed the findings, pointing out yet another conundrum: There is a higher rate of campylobacteriosis in New Zealand among urban dwellers (fewer flies) than rural inhabitants. The agency agreed that there should be a true farm-to-fork approach to controlling Campylobacter.[19]
Conundrum #3: In terms of food safety, the focus has been on C. jejuni, C. coli and sometimes C. lari. What if there are other species that cause a significant number of illnesses?
Despite great advances in detecting, reporting and investigating foodborne illnesses, the U.S. Centers for Disease Control and Prevention estimate that approximately 38.4 million cases of domestically acquired foodborne illness are caused by unspecified agents each year.[20] Many of these illnesses are probably caused by viruses, protozoans and bacteria that are not routinely tested, or for which detection methods do not exist. Because Campylobacter is notoriously difficult to culture in the laboratory, it is reasonable to assume that many of these illnesses due to unspecified agents might be caused by various species of Campylobacter.
More than 20 species are assigned to the genus Campylobacter. Human illnesses attributed to this genus are most commonly  associated with C. jejuni and C. coli, but additional species have been identified due to recent advances in methodologies. Less commonly recognized species such as C. lari and C. upsaliensis have been isolated from patients with gastrointestinal diseases.[21]
The use of newer detection technologies that do not necessarily rely on culturing is beginning to indicate that other species of Campylobacter may in fact be causing significant illnesses. In one study, 7,194 fecal samples collected over a 1-year period from patients with diarrhea were screened for Campylobacter spp. using a multiplex-PCR system. Of 349 Campylobacter-positive samples, 23.8% were shown to be C. ureolyticus, using a combination of 16S rRNA gene analysis and highly specific primers targeting the HSP60 gene. The authors of this study suggested that C. ureolyticus may be an emerging enteric pathogen that is capable of causing gastroenteritis.[22] In a review of emerging Campylobacter species causing human illness, C. concisus and C. upsaliensis were also mentioned in addition to C. ureolyticus.[23] C. fetus may be yet another emerging species capable of causing intestinal and systemic illness, although it is probably more associated with immunocompromised individuals.[24] These emerging species are all nutritionally fastidious and would probably not be detected using typical food or clinical cultural screening methods for Campylobacter. As detection methodologies improve, the impact on public health of these emerging species will become clearer.
Conundrum #4: How can a bacterium that is so difficult to grow cause so much illness?
This question has been asked many times, especially by microbiologists who are having trouble keeping the positive lab control culture alive. One of the authors (T.F.) recalls testing for Campylobacter during the early days of routine food testing. Despite the use of complex growth media and gas mixtures, it was very common to “lose” the control culture. Control cultures were expensive and difficult to obtain, so the lab technicians would go to a local butcher shop and buy a freshly butchered chicken carcass. Campylobacter was isolated every time from this source and was used as a control after biochemical identification.
Campylobacter is sensitive to drying, is nutritionally fastidious and cannot tolerate levels of oxygen found in the normal atmosphere. Although difficult to keep alive in the laboratory, some strains of Campylobacter seem able to survive quite well in the natural environment. They probably employ several strategies to survive and may work together with other types of bacteria such as Pseudomonas spp. to form stable mixed biofilms. Another survival strategy is the ability to enter into a viable but nonculturable state, becoming very metabolically inactive, thus better able to survive extreme conditions.[25]
There are probably several more conundrums associated with this complex and vexing bacterial genus. Going forward, many interesting breakthroughs relative to this organism are expected in the areas of epidemiology, detection technologies for food, environmental and clinical samples, and novel risk-reducing interventions as industry, regulatory and public health agencies, and academia collaborate to resolve the many Campylobacter conundrums.  
Timothy Freier, Ph.D., serves as division vice president of scientific affairs and microbiology (North America) at Mérieux NutriSciences.
Patrick Kennedy is information services manager at Mérieux NutriSciences.
2. Horrocks, SM et al. 2009. “Incidence and Ecology of Campylobacter jejuni and coli in Animals.” Anaerobe 15(1-2):18–25.
7. Bahrndorff, S et al. 2013. “Foodborne Disease Prevention and Broiler Chickens with Reduced Campylobacter Infection.” Emerg Infect Dis 19(3):425–430.
10. Pitkänen, T. 2013. “Review of Campylobacter spp. in Drinking and Environmental Waters.” J Microbiol Methods 95(1):39–47.
13. Taylor, EV et al. 2013. “Common Source Outbreaks of Campylobacter Infection in the USA, 1997–2008.” Epidemiol Infect 141:987–996.
14. Van Dyke, MI et al. 2010. “The Occurrence of Campylobacter in River Water and Waterfowl within a Watershed in Southern Ontario, Canada.” J Appl Microbiol 109(3):1053–1066.
15. Stuart, TL et al. 2010. “Campylobacteriosis Outbreak Associated with Ingestion of Mud during a Mountain Bike Race.” Epidemiol Infect 138(12):1695–1703.
18. Nelson, W and B Harris. 2006. “Flies, Fingers, Fomites, and Food. Campylobacteriosis in New Zealand–Food-Associated Rather Than Food-Borne.” N Z Med J 119(1240):U2128.
20. Scallan, E et al. 2011. “Foodborne Illness Acquired in the United States–Unspecified Agents.” Emerg Infect Dis 17(1):16–22.
22. Bullman, S et al. 2011. “Campylobacter ureolyticus: An Emerging Gastrointestinal Pathogen?” FEMS Immunol Med Microbiol 61(2):228–230.
23. Man, SM. 2011. “The Clinical Importance of Emerging Campylobacter Species.” Nat Rev Gastroenterol Hepatol 8(12):669–685.
24. Wagenaar, JA et al. 2014. “Campylobacter fetus Infections in Humans: Exposure and Disease.” Clin Infect Dis 58(11):1579–1586.
25. Bronowski, C et al. 2014. “Role of Environmental Survival in Transmission of Campylobacter jejuni.” FEMS Microbiol Lett 356(1):8–19.

Food Safety Spotlight: Golden Corral
Source :
By MRM Staff (Apr 19, 2016)
Golden Corral, an American family-style buffet and grill chain, first opened in 1973. The Raleigh, NC-based privately-held company has approximately 500 locations in 41 states with 9,000 employees. About 100 are company owned; the rest are franchised stores. In 2014, on average, a new Golden Corral restaurant opened every 11 business days. Also in 2014, on average a new franchise market was awarded every 13 business days. Systemwide sales for 2015 totaled $1.740 billion. 
How important is the issue of food safety?
Food safety is paramount at Golden Corral. We take the safety of our guests and employees very seriously. From a business perspective, it only takes one incident in one restaurant to have a detrimental impact on an entire chain. In the age of social media not only is information spread more quickly but also more widespread. What used to be a local issue can now become a national issue overnight.
What practices are in place to ensure food safety and quality?
We start with food safety training. All managers must be ServSafe certified. All new employees must take and pass our on-line food safety course prior to starting training in their skill position. Managers conduct a sanitation walk-thru a minimum of twice a day. The sanitation walk-thru includes checking calibration of all sanitizing dispensing units and buckets, checking cleanliness, cooler/freezer temperatures, etc. All recipes include a food safety section and all critical control points are highlighted. In addition to verifying food temperatures as part of the cooking process, temperatures of all prepared items on the buffet are verified four times a day.
We also use a pre-wash for all of our fresh produce items.
All Golden Corral restaurants receive a quarterly third-party food safety audit. In addition, our internal quality assurance (QA) department audits each franchise location five times a year and each company location eight times per year.
What is typical prep work each day?
Each day we have employees prepare fresh vegetables and fruit for our hot and cold buffets. We also cut and grind all of our steaks, ground beef, pork and pot roast in house. We have specific food safety standards in each department.
What kind of food safety training do back of house and front of house staff undergo?
All Golden Corral restaurant staff must successfully complete our Safe Tracks (food safety) on-line program. Recertification is determined by the local health department requirements. We also have a series of posters and job aids in various areas to highlight the key food safety items in that area. Periodically we will have a system-wide emphasis on various key points such as hand-washing or using our produce pre-wash.
And how does it differ or is fit to match each job?
We use both overall food safety training for everyone that focuses on hand-washing/personal hygiene, hot food hot/cold food cold, preventing cross-contamination, allergens and employee health. We then follow up with specifics in each area. 
Is the training ongoing to instill the best practices in staff?
When you dine out, what do you look for in a restaurant regarding quality and cleanliness and have you ever walked out of a place because your expectations were not met?
I look for cleanliness of facilities, employees, food/smallwares handling, etc. Yes, I have left a restaurant because of the overall lack of sanitary conditions.
What are things you do you would like to see modeled in other restaurants?
I would like to see continual reinforcement and follow-up. Having an internal QA audit in addition to third-party food safety inspection helps ensure we continue to improve as a system. Golden Corral also has a system of rewards for great performance and a system for correction/follow-up if any inspection benchmarks are not met.

Retailers, even those on wheels, can take steps to prevent contamination
Source :
By Dan Flynn (Apr 18, 2016)
Chef Roy Choi eight years ago moved on to the mean streets of Los Angeles looking for customers in his Kogi Korean BBQ truck. In his rear window came a never-ending parade of food trucks that would revolutionize street food, seemingly overnight.
By 2008 when Kogi Korean BBQ set the new standard, street vending of simple items like hog dogs and burritos had been around for about 100 years. Panel vans selling food and beverage at construction sites had been long accepted. But street food usually operated in the shadows. Their units were often called “roach coaches” because food safety was far from guaranteed.
Would chefs in food trucks costing $100,000 or more with menu offerings to  attract foodies as customers do any better with food safety? Did mobile mean unsafe? Worries were high, but now, as everyone major city seems to have 800 to 1,000 food trucks, those concerns seem to have evaporated.
How quickly did this all occur?
Four years ago, economic forecasters at Intuit Inc. made the bold forecast that by 2017 the food truck industry will be generating annual revenue of $2.7 billion.
Within a decade, many an American community has seen food trucks go from being a troublesome series of issues that included food safety to an economic contributor that’s even worth celebrating. Food truck festivals in the next week or are occurring in Fort Collins, CO, and Lawrence, KS. Others will follow, mostly over the spring and summer.
While food trucks are now part of trendy landscapes from Austin to Boston, and Los Angeles to Miami, some places still have food truck issues but food safety does not seem to be among them.
The City Council for Knoxville, TN, earlier this month approved a “mobile vending” ordinance that, among other things, set application, permit, fee and insurance requirements for food trucks. And while food safety and health inspections are routinely included in the Knoxville law, the City Council spent close to two hours debating how far food trucks with meat smokers should stay back from residential areas.
Knoxville food truck owners agreed they could deal with the 100 foot setback as long as it only applied to those smoking meat. Setbacks are typical of the zoning restrictions cities impose on food trucks.
Cities and towns never seem to cease telling food trucks where they can park. Aztec, NM, might open its public parks to food trucks this summer after nearby Farmington opened up its places to the commercial activity.
Local ordinances can provide structure to support local food truck industries, but owners say they can also be too restrictive. Caps on the number of permits and licenses, bans on parking in public spaces, and arbitrary setbacks from brick and mortar restaurants are among the restrictions food truck owners are most likely to contest with local lawmakers or in court.
While the zoning issues may never really go away, food trucks have for the most part accepted food safety as part of their business model.  Experts have told Food Safety News that food trucks present a little more challenge than brick and mortar restaurants when it comes to food safety, research shows their violations are roughly on par.
Food trucks also seem to have embraced mobile regulation when it comes to food safety. Its not uncommon for food trucks to accept GPS tracking so health officers can find them for inspections.  The public can use the systems to find out where to go for lunch.
Vendor applications are often made online, and in Portland the “Chefs Connection” is done especially for food truck owners to help them keep up on sanitation.
Improving its reputation for food safety may also be a sign of a maturing food truck industry. Dr. Dick Carpenter, author of “Upwardly Mobile: Street Vending and the American Dream,” surveyed 763 licensed vendors in the 50 largest U.S. cities.
He found 96 percent own their own businesses and 39 percent employ full or part-time workers, most for 11-12 hour days.  And, his study found, the typical food truck is turning about $35,000 in profits.
Carpenter says all cities need to do to “unleash” the economic power of food trucks is to eliminate outdated and anti-competitive regulations.

The Increasing Scrutiny of Food Packaging
Source :
By George G. Misko, Esq
I have been writing about the increased scrutiny of chemical substances used in packaging for a number of years now. In a 2009 article, I noted that factors such as a well-mounted attack by an environmental organization, a less-than-stellar report from the National Toxicology Program, over-the-top media attention and consumer outcry resulted in the deselection of bisphenol A (BPA) by some national retailers and the consideration (and sometimes passage) of legislation to ban products containing BPA. All of this was taking place despite the U.S. Food and Drug Administration (FDA) and other governmental bodies determining that current use levels of BPA in packaging materials did not present undue health or safety issues. In 2013, FDA did amend the food additive regulations to narrow the scope of uses for polycarbonate resins to exclude infant feeding bottles and spill-proof cups (so-called sippy cups) from the type of applications authorized under the regulation. However, this was done at the behest of the industry on the basis that such uses no longer existed and therefore the clearances were no longer needed. 
A few years later, in 2013, I cautioned that since much of the science surrounding endocrine disruptors is still not well understood, chemicals showing only slight effects could be branded as inherently harmful even when they are not. Furthermore, I noted that the view that the mere presence of, or exposure to, a chemical substance is considered harmful was being applied to packaging. As this trend has continued, more attention is also being directed at how FDA evaluates the safety of food packaging materials. This article focuses on the current challenges FDA is facing with respect to questions about the safety of food packaging materials and how the agency is responding.
In the food additive regulations, FDA has defined “safe” or “safety” as:
“[T]here is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance. Safety may be determined by scientific procedures or by general recognition of safety.” [21 C.F.R. Section 170.3(i)]
FDA further states that it will consider a number of factors in determining safety, including:
•    The probable consumption of the substance and of any substance formed in or on food because of its use
•    The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet
•    Safety factors that, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food and food substances, are generally recognized as appropriate
While FDA continues to use this standard for assessing the safety of food packaging materials, changes are taking place. So-called nongovernmental organizations (NGOs), which usually refer to environmental or other public interest groups, are becoming more aggressive in attacking the safety of food packaging materials. They are doing this both through citizen petitions and lawsuits when they feel FDA has not acted on their petitions in a timely manner. In addition to changes being made due to NGO activism, FDA is requiring additional testing and imposing new requirements.
Packaging for Infant Formula Requires More Testing
One area where FDA has made changes in its review of food contact notifications (FCNs) involves clearances of packaging materials for infant formula and breast milk. In the fall of 2010, FDA began to include restrictions in new FCNs on the use of food contact substances (FCSs) in can coatings for infant applications. Notably, during the first 10 years of the program, FCNs did not include restrictions on infant applications. By the fall of 2013, FDA expanded infant-use restrictions to most, if not all, new FCNs. To date, FDA has not applied infant restrictions retroactively. The agency also has included restrictions on FCNs for FCSs used in repeat-use items for infants, such as nipples, bottles and sippy cups.
These restrictions are reflected in the “Intended Use” and “Limitations/Specifications” provisions of FCNs, where the specific language used by FDA has evolved over time. Currently, unless a notifier explicitly demonstrates the safety of the FCS for use in contact with infant formula and breast milk, or use of the FCS is obviously not one that would involve an infant application, its use is excluded in the FCN clearance.
Concerns about enhanced sensitivity of infants during critical stages of development have led to the use of different assumptions for exposure assessments by FDA, in addition to potential increased toxicity data requirements. Since formula may be the sole source of nutrition for infants, FCSs may be contacting 100 percent of the diet for infants 0 to 6 months of age. This could result in an infant exposure 70 times greater than an adult exposure for the same FCS. Therefore, while the default FDA body-mass-to-food-intake ratio for adults is a 60-kg individual with an intake of 3 kg of food per day, FDA considers the typical body weight of an infant up to 6 months to be 0.6 kg with a daily intake of 0.9 kg of food. FDA also expects notifiers to make adjustments to reflect exposure specific to infant applications when conducting safety assessments for carcinogenic impurities in an FCS.
FDA Delists Previously Cleared Substances
With respect to changes due to citizen petitions submitted by NGOs, FDA recently removed the clearance for several long-chain perfluorinated compounds (PFCs) and proposed amending the food additive regulations to no longer authorize the use of seven synthetic flavoring food additives. A petition filed in March 2015 led to FDA’s amending the food additive regulations in January 2016 to no longer permit the use of three grease-resistant substances in food packaging materials such as pizza boxes, microwave popcorn bags and sandwich wrappers. The three substances are PFCs (at least eight carbons in length).
In reviewing the petition to delist these three compounds, FDA could not determine dietary exposure from food contact use of the substances due to a lack of adequate migration data. The agency also noted that there are no available toxicological studies showing reproductive or developmental toxicity for these specific chemicals; however, new data are available demonstrating the toxicity of structurally similar substances. As a result, FDA concluded that there was no longer a reasonable certainty of no harm for the food contact use of the three substances containing long-chain perfluoroalkyl ethyl. While the three substances have not been used in the U.S. since 2011, the petitioners were concerned about food packaging made containing these substances being imported from other countries.
Also in January 2016, FDA requested comments on another petition—submitted by several NGOs and one individual—proposing that the food additive regulations be amended to no longer authorize the use of seven synthetic flavoring food additives (benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, pyridine and styrene) and to establish zero tolerances for the additives. The petitioners claimed that these substances are carcinogenic based on new data, including conclusions by the National Toxicology Program and the International Agency for Research on Cancer.
While the petition deals only with the use of these substances as synthetic flavoring food additives, FDA warned that its response to the petition could also possibly affect other regulations and clearances impacting these additives. For example, benzophenone is also approved for use as an indirect food additive, and ethyl acrylate, pyridine and styrene are permitted for use by other food additive regulations and FCNs as reactants or manufacturing aids. However, the agency noted that such uses are not the subject of these food additive regulations and FCNs and, as such, may not necessarily be affected if this petition results in a regulation.
GRAS under Attack
Another area where we may see changes involves generally recognized as safe (GRAS) substances. GRAS substances are excluded from the definition of “food additive” and, thus, are exempt from the premarket clearance requirements that apply to food additives. (Food contact substances that migrate to food above a de minimis amount are considered food additives.) Over the last few years, a number of groups have criticized the GRAS program, alleging safety concerns with some GRAS substances.
By way of background, the GRAS exclusion was established by the Food Additives Amendment Act of 1958, which defined a GRAS substance as “generally recognized, among experts qualified by scientific training and experience to evaluate [their] safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.” (21 U.S.C. Section 321)
While the same quality and quantity of scientific data required to support a food additive petition are needed to support a GRAS determination, there is no requirement that the data be provided to FDA prior to marketing a product on this basis. In 1958, FDA published a list of GRAS substances in the Code of Federal Regulations; however, many substances that were considered GRAS by the food industry were not included in that list. As a result, when manufacturers needed to show a customer that a self-determined GRAS position was justified, they would write the agency and request an informal opinion letter.
FDA stopped issuing informal GRAS opinion letters in 1970 and, in 1972, conducted a rulemaking to establish a voluntary GRAS affirmation petition process. Under the process, an individual could petition FDA to review and affirm the GRAS status of a substance. FDA would then publish a notice of the filing in the Federal Register, request comments, conduct a comprehensive review and then publish a final rule in the Federal Register. However, once the GRAS petition was “accepted for filing,” common industry practice held that the substance could be marketed at that point as GRAS without objection by FDA, which was clearly the case as often FDA did not even bother to complete the petition review process with the publication of a final rule.
The next development took place in 1997, when FDA proposed a GRAS notification rule. Under this program, a manufacturer notifies FDA that a particular use of a substance has been determined to be GRAS. While the rule was never finalized, the agency started accepting GRAS notifications in 1998 and effectively suspended the GRAS petition process. After evaluating the data, FDA informs the notifier that: it has no questions currently as to the basis for the determination, or it has determined that the notice does not provide a sufficient basis for a GRAS determination. FDA may also cease to evaluate the GRAS notice at the notifier’s request.
Much of the criticism of FDA’s GRAS program focuses on the fact that FDA has not issued guidance on how to document a GRAS determination. A Government Accounting Office (GAO) report, Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS), issued in February 2010, mentioned that the 1997 proposed rule on a voluntary notification program had yet to be finalized. Furthermore, said the GAO, while FDA regulations require that the GRAS status of a substance be reconsidered as new scientific information emerges, the agency has not systematically reconsidered GRAS substances since the 1980s. One of the GAO’s recommendations was that FDA should develop a strategy to require any company that conducts a GRAS determination to provide FDA with basic information about the determination. FDA did request further comments on the proposed 1997 GRAS notification procedure in December 2010.
Concern about FDA’s lack of sufficient information to assess the safety of GRAS substances was also expressed in a November 2013 Capstone Report by the Pew Charitable Trusts, entitled Fixing the Oversight of Chemicals Added to Our Food. This report recommends that Congress update the Food Additives Amendment of 1958 to ensure that FDA approves the use of all new chemicals added to food and reviews changes to existing uses of previously approved additives. 
An attack on FDA’s GRAS notification program was launched in February 2014 when the Center for Food Safety filed a lawsuit to vacate the 1997 proposed rule, which would effectively reinstate the petition process until FDA promulgates a final GRAS rule. Under a Consent Decree issued by the U.S. District Court for the District of Columbia, FDA agreed to issue a final rule on the GRAS review program by August 31, 2016. NGOs retained the option of pressing for further action, claiming FDA overextended its authority, if they are unhappy with the results.
Another development took place in August 2014, when the Grocery Manufacturers Association (GMA) announced a GRAS modernization initiative that will involve the development of a publicly available standard (PAS) for GRAS determinations. The PAS will be developed by an independent body of experts in a public process and will be suitable for accreditation. Additionally, a GMA-sponsored, publicly accessible database will be established that will list information on GRAS assessments conducted by the food industry. At this point, the database is planned for direct additives only.
The attacks on the safety of food packaging materials will continue to escalate. Speaking at Keller and Heckman’s 16th annual Food Packaging Law Seminar, October 14, 2015, in Arlington, VA, Dr. Dennis Keefe, director of the FDA Office of Food Additive Safety, stated that the agency needs to look at some of the decisions it made 30 to 40 years ago and review them based on current scientific understanding. He also suggested that cooperation between FDA and industry is necessary for food companies to gain the confidence of consumers. He added that FDA needs information about the safety of chemicals in a more timely manner.
As questions continue to arise about the safety of food packaging materials, the food packaging industry will need to have solid science to show that their products are safe, and they will need to effectively communicate this information with government regulators and consumers. For substances that capture the public limelight, if this cannot be accomplished, we could see the next deselection occur, as happened with BPA.  




Internet Journal of Food Safety (Operated by FoodHACCP)
[2015] Current Issues

Vol 17.64-74
Sanitation and Hygiene Meat Handling Practices in Small and Medium Enterprise butcheries in Kenya - Case Study of Nairobi and Isiolo Counties
Sharon Chepkemoi, Peter Obimbo Lamuka, George Ooko Abong’ and Joseph Matofari

Vol 17.25-31
Combined Effect Of Disinfectant And Phage On The Survivality Of S. Typhimurium And Its Biofilm Phenotype
Mudit Chandra, Sunita Thakur, Satish S Chougule, Deepti Narang, Gurpreet Kaur and N S Sharma

Vol 17.21-24
Quality analysis of milk and milk products collected from Jalandhar, Punjab, India
Shalini Singh, Vinay Chandel, Pranav Soni

Vol 17.10-20
Functional and Nutraceutical Bread prepared by using Aqueous Garlic Extract
H.A.R. Suleria, N. Khalid, S. Sultan, A. Raza, A. Muhammad and M. Abbas

Vol 17.6-9
Microbiological Assessment of Street Foods of Gangtok And Nainital, Popular Hill Resorts of India
Niki Kharel, Uma Palni and Jyoti Prakash Tamang

Vol 17.1-5
Assessment of the Microbial Quality of Locally Produced Meat (Beef and Pork) in Bolgatanga Municipal of Ghana
Innocent Allan Anachinaba, Frederick Adzitey and Gabriel Ayum Teye

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