Step up food safety checks
Source : http://www.thestar.com.my/opinion/letters/2016/04/11/step-up-food-safety-checks/
By thestar.com (Apr 11, 2016)
MEDIA reports on cases of food poisoning in the country, especially involving students, seem to be on the rise lately. The National Institute for Occupational Safety and Health (NIOSH) views the matter seriously and would like to urge everyone involved, including the relevant authorities, school administrators, owners of eateries, caterers, food handlers and parents to take appropriate steps to prevent food contamination from becoming a serious health threat.
We do not want to see a repeat of the recent food poisoning case in Batu Gajah, Perak which claimed one life and left several others needing hospital care.
Less than a month after the incident in Batu Gajah, where victims consumed pesticide-contaminated food bought at a stall there, another food poisoning episode took place at Sekolah Menengah Sains Tapah in Perak. In this incident, 43 students and a teacher fell sick after eating roti jala with chicken curry at the hostel. It was later found that the chicken used in the curry was contaminated by salmonella bacteria.
It was the second case of food poisoning reported in the school in the past three years. In October 2013, more than 270 students suffered food poisoning from a chicken dish served at the school’s dining hall.
Close on the heels of the case at the boarding school came another in Sekolah Kebangsaan Tiong in Kota Baru, Kelantan where 29 pupils suffered food poisoning after eating spicy chicken in the school canteen.
This canteen has been closed for two weeks to facilitate an investigation and the operator risks losing his contract if the Health Department’s investigation finds him to be negligent.
Students must be protected from not only accidents and crime within the school compound but they should also have access to safe and hygienic food in the canteen or dining hall.
As for food outlets and restaurants, the owners must ensure that people whom they hire must be qualified and practise hygienic and safe food preparation and handling.
In the wake of the recent food poisoning incidents, there should be close monitoring on food preparation and handling as well as frequent checks on eateries and school canteens throughout the country.
In Malaysia, roadside food stalls are mushrooming and frequented by the public who seem to be unsure whether these stall owners have certificates from the Health Ministry or permits from local authorities.
Furthermore, many restaurants, cafes and outlets at food courts today hire foreigners to cook and prepare food.
I believe that random checks and on-the-spot compound issued by the ministry and local authorities will help improve the cleanliness of the eateries and ensure safe and hygienic food preparation and handling.
The Health Ministry has to conduct more frequent inspections at all eateries as compared to the current practice of once a year, or when there are food poisoning cases or customer complaints. Local authorities also have to step up their inspection at eateries in their jurisdiction and focus on the roadside stalls to weed out the unlicensed ones.
At the same time, the authorities should recall unsafe or contaminated food in the wet markets, mini markets, supermarkets or hypermarkets and impose severe punishment on wrongdoers.
Under the law, owners or operators of eateries are not supposed to employ food handlers to work at their premises unless these people have undergone training and have been medically examined and vaccinated by registered medical practitioners. Failing to do so, the eatery owners or operators are liable to a maximum fine of RM10,000 and a jail sentence not exceeding two years.
A similar penalty awaits any food handler in any eatery who fails to undergo training or obtain a Food Handler Training certi-ficate.
The Food Act 1983 is a very comprehensive law providing protection to the public against health hazards and addressing wrongdoings in the preparation and sale of food. The Food Hygiene Regulations 2009 of the Act covers registration of food premises; conduct and maintenance of food premises; food handler; special requirements in handling, preparing, packing, serving, storing and selling of specific food (meat, fish, ice cream and frozen confection, milk, ice and vending machine); and carriage of food.
Our humid weather promotes the breeding of harmful pests such as cockroaches, rats and flies that can contaminate the food. This is another aspect that should not be ignored, besides cleanliness of tables and utensils, toilets and food storage facilities.
As for primary school pupils, teachers and parents have to teach them food safety and how to spot spoiled food by using senses like sight, smell and taste.
School administrators or parent-teacher associations have to ensure that sinks in school canteens are properly maintained and soap is provided for the students to clean their hands before and after meals.
For safe food to reach end users, the relevant authorities have to ensure that food producers and handlers comply with safe and hygienic practices throughout the supply chain. Consumers have to be conscious of food safety and avoid dirty eateries.
Can you rely on Tennessee's food safety system?
Source : http://www.tennessean.com/story/news/2016/04/09/nashville-restaurant-health-inspections/79901956/
By Jim Myers (Apr 10, 2016)
Lifting the steam pan lid, Yvonne Rodriguez takes her thermometer, cleans it with a sanitary wipe and slides it into the mashed potatoes. She checks the temperature in two or three more places and makes a note on a form, neatly held by her metal clipboard.
The note says, “Mashed pot. placed on steam table not reheated to 165° F. Reading 57° F.”
That is an alarm bell for anyone interested in food safety because food held between 40 and 140 degrees is a breeding playground for a host of foodborne illnesses.Rodriguez is one of a dozen inspectors who perform about 13,500 inspections and re-inspections annually for the Metro Public Health Department, under contract for the state.
Shelf-life and temperature are renewed points of emphasis for the Tennessee State Department of Health’s restaurant inspection program, which underwent a significant overhaul last year for the first time since 1978.
The onus is clearly on the restaurants to do the right thing, day in and day out, making the health department simply the second line of defense in the battle for food safety.
While that may seem scary, large outbreaks are remarkably rare compared with the volume of food prepared and served every day. However, for companies such as Chipotle, outbreaks of salmonella, E. coli and the norovirus sickened hundreds of customers and employees across more than a dozen states in 2015.
It also showed how our collective appetites can quickly change. According to a recent study by AlixPartners, a global business consulting firm, “28 percent of diners surveyed say they would never eat at a chain affected by a food-safety outbreak, regardless of the geographic location of the outbreak.”
A triple-barreled maelstrom of vomit on both coasts certainly gets the attention of the dining public, along with questions about what exactly is being done to make sure our food is safe. It also begs the question whether restaurant scores, without context, really mean anything.
In Tennessee, however, it remains difficult for everyday diners to make informed decisions on food safety. Even with online databases and a new mobile app created by the State Health Department, information about many scores and violations is more than nine months out of date because of data glitches that still aren't resolved.
A clean, well-lit place
At first glance, Ruby's Kitchen is clean and well-organized. After introductions and pleasantries with manager Charlene Bost, inspector Rodriguez gets to work, checking temperatures along the steam table first.
She is soft-spoken and smiles easily, but is clearly focused on the task at hand.
Rodriguez takes temperatures every step of the way, including the hot water underneath the steam table pans, the pots of food cooking on the stove and in the freezers and walk-in cooler. While all of the refrigerated foods seem to be marked and in compliance, some have exceeded the newly introduced seven-day limit for using leftovers and are immediately thrown out.
Finally, after a full hour inspecting other areas, including the exterior, and running the dishwasher through three separate cycles to check the strength of the sanitizer, Rodriguez sits down to finish her report. Once she tabulates the score, she pulls out a thick marker and writes the number 69 as big as the bright, yellow page will allow. It's not what any restaurant owner or manager wants to see.
Owner Aftab Siddiqui was not present the day of the inspection. While sounding understandably chagrined on the phone later, he took full responsibility for the restaurant's shortcomings, and was even complimentary of the role that inspectors play.
“The way I look at it, it’s a lot like coaching," Siddiqui says. "Sometimes we forget about the small things and that they can have a big impact. We need to step up and be more careful.”
Ten days later, Ruby's received a 98 out of 100 during the re-inspection.
The yellow form
By law it’s supposed to be hard to miss; a canary yellow public posting of the establishment’s most recent inspection score. The restaurant’s numerical grade, based on a 100-point scale, is writ large in marker for all to see.
Numbers don’t lie, but when it comes to inspection scores, they only tell part of the story.
From a consumer standpoint, a high score can be misleading. Let’s say your favorite place ends up with a 90 from its initial inspection. Sounds pretty good, right?
That 90, though, may include two significant violations (five points each), such as keeping food at improper temperatures as was the case in the first inspection at Ruby's, which could quickly call into question the restaurant’s food-handling practices.
A close examination of the form shows all of the points of inspection, the checked boxes for various violations and whether the final number was from the initial inspection or is the adjusted score from a follow-up inspection. It’s an important distinction to which most consumers don’t pay attention.
If the score posted on the wall doesn’t have the words “follow up” on it, you may be visiting during the 10-day window before the health department has verified the issue has been fixed. That's why an understanding of exactly what kinds of violations occurred during the inspection is critical in helping customers decide whether it’s reasonably safe to visit a restaurant.
The guardians of the gall
It’s a gross understatement to say that nobody wants a customer to get sick from a foodborne illness in a restaurant. Not the owner, the employees, and least of all, the diner who trusts the business.
The restaurant inspection program is designed to keep that from happening by verifying and sharing the latest information and best food-handling practices within the restaurant industry.
The state of Tennessee took an awfully long time to catch up with the rest of the country on restaurant inspections. It only began using the 2009 FDA Food Code guidelines on July 1, 2015.
“Tennessee was one of the last states to adopt the new regulations,” says Hugh Atkins, director of Environmental Health for the state, noting that a significant overhaul of the program had not happened in almost 40 years.
Atkins cited the evolution of food trends during that time, such as the charcuterie boom, sushi and sous vide cooking (long, low temperature cooking with vacuum-sealed bags in hot water baths) as examples of what has changed.
Inspections through positive reinforcement
"Is our role making sure restaurants are clean? Sure, that’s part of it, but our biggest role is making sure people don’t get sick. That’s where (the state) wants us to put all of our attention to now," says Steve Crosier, director of Metro's Food Protection Services.
Compared to other states, such as New York, Pennsylvania and California, Tennessee’s restaurant inspection program is largely toothless, unless repeated violations require the revocation of a permit. In Tennessee there are no fines associated with violations and poor grades, only more inspections, and about the only ways the health department would immediately close the doors of a business would be the imminent threat of an outbreak or something like raw sewage coming up through the plumbing.
While New York City relies heavily on revenue generated through inspection violations (it brought in $45.6 million in 2011, according to the New York World), 95 percent of Metro Health’s program is funded by permits alone. What this creates is a system that’s less punitive and built more education.
Can't touch this
When the new requirements went into place last year, the inspectors offered a six-month grace period for six of the new critical areas of inspection. That was easy for many of the restaurants that are part of national chains, because many of those changes were already implemented into the company's standard operating procedures in other states. For the independents and mom and pops, Crosier said there was a lot of education.
"We wanted to give industry time to adjust," says Crosier, noting that the soft period ended the first of this year.
Two of the major changes involve date-marking and handling. For foods that are prepared and then saved for later use, they must be clearly marked with the date of preparation so employees and managers will know immediately if the food can be used. According to Crosier, this has been a big adjustment.
"It used to be we looked at it and used our best judgment," he said. "Now, it’s seven days. Use it or throw it away."
Another sticking item, so to speak, is the new rule prohibiting barehand contact with ready-to-eat foods, such as garnishes in a drink or cold cuts when making a sandwich. Now, there needs to be some kind of barrier between the food item and the handler's skin, whether it's gloves, tissue paper or tongs.
While restaurants and bars may petition for variances, they need to have an approved control plan in place that demonstrates why their procedures don't pose a risk.
Less than a year into the new regulations, two state legislators are looking to roll back the barehand contact restrictions. However, neither of the sponsors of the regressive bill, Sen. Reginald Tate, D-Memphis, nor Rep. Pat Marsh, R-Shelbyville, responded to requests for comments regarding their rationale.
Who’s keeping the score?
The responsibility of food inspections falls upon the shoulders of two state departments, Health and Agriculture.
While restaurants fall under the Health umbrella, food processing and grocers are the responsibility of Agriculture. It's a division of labor that seems to make sense.
Together, the two departments joined resources to develop a mobile app so consumers would have inspection scores readily available. The app works remarkably well and is GPS-enabled so you can check out the relative hygiene of places as you drive along.
In theory it automatically displays the most recent inspection score. You can drill down deeper for each business and find earlier scores, as well as the list of violations. The app also tells if the inspection was "complete" or a "follow-up," making it a well-designed and invaluable tool.
When the state moved to the new regulations in July, though, the data dried up. Hugh Atkins, the director of the Environmental Health Division, said it was a data coding issue between the state and the third-party provider. The new forms add a lot more information, he said.
Unfortunately for the consumer, the app and the state's own website and database, have not been fully updated in more than a year. For some restaurants, that means scores from their past two inspection cycles are missing, all because of what should be a very simple data-coding issue.
Initial estimates from the state said the information would be available online by March 25. After missing that deadline, spokesman Woody McMillin said, "We do not know if that is due to errors in how the information is processed by TDH staff, if there is some type of system bug preventing the information from being processed properly or if there is some programming or software issue. We are working with a company named MicroPact (formerly called Iron Data) to learn what is causing the problem."
McMillin could not offer a new date for the fix.
In the meantime, for people interested in checking scores before they go out to eat, there's little recourse beyond just showing up. Until full access to the digital data is resumed, spokespeople say, "Consumers can still see the full report for each restaurant’s most recent score posted at the restaurant."
Reach Jim Myers at 615-259-8367 and on Twitter @ReadJimMyers.
How it's supposed to work
Restaurants are typically inspected once every six months, without warning. However, under new state guidelines, the frequency may go up or down based on the restaurant’s overall history.
When certain violations are discovered, once called "critical violations," but now simply referred to as “food-borne illness risk factors,” it automatically triggers a re-inspection.
If the restaurant has violations that are simple to correct and can be addressed immediately, the re-inspection takes place while the investigator is still there. That adjusted follow-up score is then posted until the next inspection, usually a half-year later.
However, some violations can’t be fixed immediately, such as the dishwasher sanitizer issue that plagued Ruby’s Kitchen during our visit and required equipment repair. In such cases, the establishment has 10 days to fix the problem before being re-inspected. Until then, it has to post the initial inspection score on the wall.
The story at a glance.
•It remains difficult for everyday diners to make informed decisions on food safety.
•Compared to other states, Tennessee's inspection program is largely toothless
•Inspection focuses more on education than enforcement
•Department of Health data is out of date because of glitches that still aren't resolved.
•High food scores can be misleading for consumers.
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Food industry cost cutting: Cutting food safety, too?
Source : http://www.startribune.com/food-industry-cost-cutting-cutting-food-safety-too/374931331/
By Mike Hughlett (Apr 7, 2016)
Is cost cutting in the food industry posing a risk to food safety?
That was a question posed to General Mills CEO Ken Powell during a recent earnings conference call by Eric Katzman, a stock analyst at Deutsche Bank.
With sales growth being squeezed across the packaged food business, General Mills and a host of other companies have significantly cut costs to maintain profit margins.
“I’ve heard from a number of other CEOS, both currently in the industry and formerly in the industry, who are getting more concerned about the pressure to cut costs and the risks to food safety and quality,” Katzman said.
“You guys (General Mills) have done a very good job over time but even you had a recall earlier.” In October, General Mills recalled 1.8 million boxes of gluten-free Cheerios and Honey Nut Cheerios because they accidently contained wheat.
Powell replied that the company is “very focused on product safety and product quality. It’s central to our mission. . . Consumer trust is job one for us.”
Indeed, recalls are expensive while large outbreaks of foodborne illness can batter a company’s reputation.
Recalls made in conjunction with the U.S. Food and Drug Administration have been rising in recent years. In the FDA’s fiscal year ending Sept. 30, there were 3,265 food and cosmetic related recalls, up from 2,549 and 1,777 in the two previous fiscal years.
More recent data isn’t available, but the past two months have been rife with recalls related to the elemental task of keeping packaged food free of foreign matter – glass, plastic, metal, etc.
Snyder-Lance, a big snack food maker, recalled some of its Emerald brand snack packs of cashews because of possible glass contamination. Nestle recalled some of its Lean Cuisine and Stouffer’s frozen meals, as well as DiGiorno frozen pizza. Errant glass was also to blame.
Closer to home, Austin-based Hormel Foods recalled 450 pounds of Dinty Moore stew, due to possible contamination with pieces of a broken flashlight. And Hormel’s Applegate division recalled 9,000 packages of chicken nuggets after some consumers found pieces of plastic in the product.
The Increasing Scrutiny of Food Packaging
By George G. Misko, Esq.
The Increasing Scrutiny of Food Packaging
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.
Lawmaker seeks increased access amid raw milk warnings
Source : http://www.foodsafetynews.com/2016/04/lawmaker-seeks-increased-access-amid-raw-milk-warnings/#.Vwr9qk7yWUl
By Coral Beach (Apr 6, 2016)
As Louisiana lawmakers consider whether to allow on-farm sales of raw milk, health officials in Utah and Tennessee are echoing last month’s federal warning about the dangers of drinking raw milk, citing outbreaks and deaths.
As many as 3 percent of the people in the United States drink raw — aka unpasteurized — milk, according to the U.S. Centers for Disease Control and Prevention, which renewed its warnings about the practice last month.
The proposed change to Louisiana’s law includes a provision that would require producers of raw milk to test for coliform. Data reported by Utah health officials shows such tests did not prevent or detect a deadly outbreak there in 2014.
“Routine somatic cell and coliform counts of raw milk do not ensure its safety,” scientist from Utah’s health and agriculture departments reported. “Consumers should be educated that raw milk might be unsafe even if it meets routine testing standards.”
The Utah warning cites a deadly outbreak in 2014 linked to raw milk from an unnamed dairy. “Dairy A” followed Utah law, submitting monthly raw milk samples to the state for somatic cell and coliform counts. The safety measure failed.
From May 9 through Nov. 6, 2014, a total of 99 people, including one who died, were infected with Campylobacter jejuni that was later identified in the dairy’s raw milk and confirmed as the outbreak isolate of the pathogen, according to data from Utah’s follow-up lab tests.
Fifty-nine of the victims reported drinking raw milk from “Dairy A” in the 10 days before becoming ill. The other 40 patients reported either drinking raw milk from the dairy or coming into contact with another outbreak victim.
Tennessee chimes in to boost CDC’s voice
Tennessee officials joined the recent chorus of public health officials and scientists warning about the potential life-threatening pathogens present in unpasteurized milk, known as raw milk. The Tennessee warning Monday came as a reinforcement to a similar caution issued last month by CDC.
The CDC’s warning March 18 came after the agency discovered two Listeria monocytogenes patients — one of whom died — had been infected in 2014 by the same pathogen isolate California officials had detected in samples of raw milk from an organic dairy in Pennsylvania that had been taken to the West Coast for a conference in late 2015.
Tennessee Health Commissioner John Dreyzehner, who is a medical doctor as well as a public health administrator, questioned whether endangering lives, especially children’s lives, is worth the “perilous risk” associated with raw milk.
“In the last three years, Tennessee has experienced outbreaks associated with drinking raw milk that was not pasteurized. Notably, in 2013, nine residents under the age of nine years were sickened with E.coli O157 bacteria. Five required hospitalization for life-threatening kidney failure. Fortunately, none of the children died,” according to the Tennessee warning issued yesterday.
Tennessee’s state epidemiologist Dr. Tim Jones said in the public warning that raw milk advocates who say the risk is worth it because there haven’t been a lot of illnesses reported aren’t taking into account modern diagnostic techniques.
“No one really knows how many people may have been harmed by drinking raw milk because the effects can mimic other health issues, and illnesses and deaths in the past may not have been properly linked to the contaminated milk they consumed,” Jones said.
Weighing in on the part of the dairy cows, veterinarian John Dunn, who directs zoonotic disease outbreaks for the Tennessee Department of Health, encouraged the public to remember basic anatomy in his raw milk warning. But he didn’t blame the cows or the dairies — it’s Mother Nature’s fault.
“If you think about where milk comes out of a cow or goat, you know it’s not far where manure comes out,” said Dunn.
“Even very conscientious cleaning of the udder and care while milking can’t prevent all risks of contamination during the milking process. Pasteurization kills bad bacteria that inadvertently contaminate milk and makes it safe to drink.”Third time at bat in Louisiana
The potential danger of raw milk consumption is something individuals should weigh for themselves, Louisiana State Sen. Eric LaFleur contends. He is sponsoring a bill for the third time that seeks to allow on-farm sales of raw milk directly to consumers.
LaFleur told The Times-Picayune newspaper he understands the safety concerns and that he “would be concerned about it and take the appropriate steps to correct it” if people die from drinking raw milk.
His bill is assigned to a committee, where it died two times before. Among its provisions are:
•a 500-gallon monthly sales limit for each dairy;
•labels must include the name and address of the farm or dairy, with the seller’s contact information
•labels must carry the statement “Raw Milk: This product is fresh whole milk that has NOT been pasteurized.”
•testing requirements for coliforms and documentation that the “rolling three-month average” is less than 25 coliforms per milliliter; and
•a mandate that “raw milk shall not contain zoonotic pathogens including Salmonella spp., Escherichia coli 0157:H7, Campylobacter spp., and Listeria monocytogenes.”
Louisiana’s agriculture commissioner and state health officials are on record as being opposed to the bill. Department of Health and Hospitals staff spoke against the bill last year and are scheduled do so again this spring.
CDC take on contamination vectors and outbreaks
Along with the U.S. Food and Drug Administration, the CDC has special pages on its website devoted to educating consumers about the potential dangers of drinking raw milk ad eating raw dairy products. Both agencies recognize pasteurization as the only method for removing pathogens from raw milk.
According to the CDC, ram milk can become contaminated in a variety of ways, including:
•Cow feces coming into direct contact with the milk;
• Infection of a cow’s udder;
•Cow diseases such as bovine tuberculosis;
• Bacteria that live on the skin of cows;
•Environment such as feces, dirt and processing equipment;
•Insects, rodents and other animal vectors;
•Humans by cross-contamination from soiled clothing and shoes or boots.
The CDC has found a correlation between states that allow the sale of raw milk and the number of outbreaks they have. Data from actual victims shows people who are sickened in raw milk outbreaks are 13 times more likely to require hospitalization than those sickened by outbreaks linked to pasteurized milk.
In 2014, the CDC reported on data collected from outbreaks associated with raw milk in the U.S. from 2007 through 2012.
•81 outbreaks across 26 states due to consumption of raw milk;
•979 illnesses total from the outbreaks;
•73 people were hospitalized;
•Most of the illnesses were caused by Campylobacter, Escherichia coli O157, or Salmonella;
•81 percent of the outbreaks occurred in states where the sale of raw milk was legal at the time.
Ensure food safety
Source : http://www.dailyexcelsior.com/ensure-food-safety/
By dailyexcelsior.com (Apr 7, 2016)
Adulteration in food items has become rampant. Not to speak of food items like milk and milk products, oils, ghee and condiments etc. even fruits and vegetables are given some sort of unhealthy chemical treatment to make them appear ripe which they in reality are not. The classic case of M/s Khyber Agro Farms Pvt. Ltd for making adulterated food items can be cited in this context. It shows how selfish persons and organizations play havoc with the health of the people. In a landmark judgment the Judicial Magistrate (Sub-Judge) Budgam, Imtiaz Ahmad Lone, imposed Rs 9 lakh as fine and awarded 6 months imprisonment to M/s Khyber Agro Farms Pvt. Ltd for manufacturing sub-standard, miss-branded and unsafe food items and directed for lifting of food samples from this company for testing. The Magistrate has passed strictures against Food Analyst Kashmir and accused him of conniving at the crime of adulteration of food. In its judgment the court observed that the Food Analyst Kashmir has given clean chit in favour of the accused company and in favour of the other companies. It has to be noted that the High Court of the State had already imposed Rs 10 crore penalties on the company for finding various food items of the accused company as substandard and adulterated. In order to prevent further consuming of adulterated and substandard food items by the general public, the court directed Commissioner Food Safety to collect the samples of all food items of the company and other companies for testing.
This is a typical case of a company with huge financial assets caught indulging in providing adulterated food items to the people without qualms of conscience.
We would entreat the Food Commissioner to take due notice of the Khyber Industries case and ensure that adulterated food items are not bought to the market to cause damage to public health. Government machinery has to move fast in this direction.
Paying Heed to Food Safety
Source : http://www.cstoredecisions.com/2016/04/06/paying-heed-food-safety-2/
By Howard Riell (Apr 6, 2016)
In the wake of the publicized instances of food-borne illnesses such as the Norovirus outbreak at Chipotle, more convenience stores are protecting their operations against similar operational risks.
Many c-store operators are looking at a variety of potential danger areas, from food preparation equipment to storage containers and ice machines, honing their food safety policies and procedures along the way.
Jeff Oppenheim, director of food service for Sampson-Bladen Oil, which operates 79 Han-Dee Hugo’s convenience stores throughout North Carolina, said his chain is working to grow its proprietary foodservice program in new stores, focusing on food safety.
Han-Dee Hugo’s foodservice program varies from location to location, but includes branded Subway sandwich outlets as well as fried chicken, hot dogs, burgers, pizza, taquitos, egg rolls, breakfast sausages and, coming in late spring, Little Caesars Pizza. Nine stores currently offer foodservice.
Many of Sampson-Bladen’s stores are equipped with self-cleaning ice machines, though managers are instructed to run a cleaning cycle once a week. The c-store also has an outside service vendor come in quarterly, break down and clean all units.
“But every month we break down those machines and clean them ourselves to maintain the quality because there is nothing like getting a piece of ice with a black chunk from mold,” Oppenheim said. “Mostly we go in and actually open the machine and clean behind the doors. We take out some of the shields and clean those pieces. We teach our managers how to maintain those.”
The self-cleaning feature helps out a lot with maintenance, he added. “I have one ice machine that does not have the self-cleaning piece in it; and that one is always heavily soiled, and so it is taken apart and cleaned more often.”
When food deliveries arrive the boxes are marked to ensure good first-in, first-out product rotation. To help expedite the process, the chain also uses automatic label printers in many locations.
“If you have a big operation, I recommend getting something like that,” Oppenheim said. “All you do is push a button and they print out a sticker based on your parameters. It’s good if you’re doing the same program at different stores.”
Newer models include time and temperature data, which are logged automatically. Store staffers do temperature checks at least twice per day, and up to four times at 24-hour locations.
STORAGE AND MORE
For food storage, Han-Dee Hugo’s stores are equipped with stand-alone refrigerators and freezers, and some have walk-in units. Managers and employees are trained to make sure their coolers are well kept and clean, especially the fins on the condenser unit.
“Make sure you clean those weekly,” Oppenheim said. “We have to go in and actually take a simple paint brush and keep those clean. Keep the dust off of them and over the long haul that will save you a ton of maintenance money. It’s as simple as giving someone a paint brush and wiping those off and keeping them dust-free.”
When it comes to the food prep area and equipment, Sampson-Bladen uses the cleaning and sanitizing products of a well-known supplier.
“They are nationally known, and the chemicals they use are safe for food,” Oppenheim said. “We break everything down every night and sanitize it from top to bottom.”
A maintenance schedule calls for managers to mark off individual tasks to make sure none are overlooked or forgotten. “That’s huge, too.”
Garry Thomas, district manager with Asheville, N.C.-based Mountain Energy Corp., which operates 20 Shell-branded convenience stores, pointed out that food prep is a challenge in c-stores due to the danger of cross-contamination from non-foodservice employees.
“What you could end up having is the manager or cashier come over to help with the food area without washing his hands simply because he is running and hustling over there and then coming back,” Thomas said. “If you have the sections side by side I think you are more apt to have cross-contamination coming over from handling money into food.”
Mountain Energy locations include four Dairy Queen units and a single Schlotzsky’s Deli restaurant, with more planned. The Schlotzsky’s section of the store operates from 10:30 a.m. to 10 p.m., in a 600-square-foot space.
Cleaning the bake oven is less of a challenge, Thomas said. “Your baker is usually only baking five or six hours a day. Once that’s done, then his time is just designated to that oven to make sure everything is cleaned up.”
Ensuring effective food safety practice is simple but not easy. It consists mainly of drafting proper policies and procedures and making sure store personnel follow them carefully.
When it comes to food safety and storage in general, operators must be sure to follow the FIFO (first-in, first-out) storage practice. By doing so, said consultant Howard Algeo with ROG Consulting LLC in Fairfield, Conn., products are more likely to be used before their expiration dates.
“It also helps keep storage areas cleaner and free of pests,” Algeo said. When storing product, always avoid cross-contamination. Keep chemicals separate from food products and store ready-to-eat foods above raw products.
Freezers and cold storage equipment require constant monitoring. A major food safety concern with freezers and cold storage is overstocking. When storage units are overstocked it is harder to maintain temperature due to lack of air circulation. This will not only put the food temperature at risk, but it will also overwork the equipment, leading to equipment failure. Overstocked units are also more difficult to clean and make it more challenging to rotate stock.
Jennifer Vespole, director of foodservice for Whitehouse Station, N.J.-based Quick Chek Corp., which operates QuickChek Food Stores, said a crucial part of safe food storage is ensuring that food items are appropriately placed in the refrigerator or freezer.
“They should be off the floor, properly packaged and sealed, labeled, and code-dated—first in, first out,” Vespole said.
Managing the menu is also important, she added, since too many SKUs simply may not fit in the available storage space.
All food contamination begins with human behavior. First and foremost, all cooked food products must be cooked to the appropriate levels to kill off bacteria that cause food-borne illness.
“There are a few things to keep in mind when preparing food,” Algeo said.
These include practicing good personal hygiene, avoiding time/temperature abuse and preventing cross-contamination.
“Always wash hands before putting on gloves, and change gloves when switching products and before beginning a new task.”
Employees should be instructed to minimize the amount of time that food spends in the temperature danger zone by taking out of refrigeration only small amounts of a product at a time. “Put items back into the coolers and cold holding units as quickly as possible,” said Algeo, “and always prep food on equipment that has been properly cleaned and sanitized.”
Food-handling equipment and all contact surfaces must be properly cleaned and sanitized by using the proper procedures.
“Always test chemical sanitizers to make sure they are at a safe and effective level,” Algeo said. “Follow the proper cleaning and sanitizing procedures whenever beginning a new task, or switching products, or after four hours of continual use.”
“This is where 80% of diseases are transferred, whether it be the rhinovirus, the common cold, or the norovirus, which caused one of the Chipotle outbreaks,” noted Tim Powell, vice president and consulting food-and-beverage practice leader for Q1 Productions Consulting Services in Chicago, which designs and develops training courses for the food-and-beverage industry.
Food Safety Dept gears up to check milk adulteration
Source : http://www.tribuneindia.com/news/chandigarh/community/food-safety-dept-gears-up-to-check-milk-adulteration/218473.html
By tribuneindia.com (Apr 5, 2016)
To tighten the noose around dairy farmers and vendors indulging in the adulteration of milk, the Department of Food Safety and Standards, Chandigarh, is all set to start the surveillance of the milk samples sent to Chandigarh from the surrounding areas. A consolidated report regarding it, along with the specified areas delivering the lowest quality or adulterated milk, will be sent to the Union Government.
For the purpose, the department will make the use of the advanced electronic milk adulteration tester (EMAT) received from the Union Government. The EMAT can test fat, protein content, SNF (solid not fat), water content, presence of glucose and electrodes in milk.
“The department has received the EMAT, costing Rs 3 lakh, as a gift for Chandigarh after it stood first in food safety awareness among states,” said Sukhwinder Singh, designated officer, Department of Food Safety and Standards, Chandigarh.
“We intend to utilise the machine to create awareness about milk safety. The idea is not to punish or snub each defaulter but to create so much awareness among the general public that the defaulters are pushed out of the market thereby forced to provide quality milk ,” he added.
Singh said the Union Government will send officials to conducts trials of the machine. “Only after that it will be decided as to where the machine should be installed,” he said.
Significantly, the machine installed in the newly launched mobile food testing laboratory checks adulteration but the EDMAT will take the tests a notch higher with its advanced testing features.
“This initiative is part of our initiative to sensitise the public about adulteration. It will also act as warning for the suppliers and ensure that the product supplied by them confirms to the food safety standards,” Singh said.
He further said the samples that failed the test would be sent for further examination in food testing laboratories for confirmation.
For studies on GMO food safety, does length matter?
Source : https://www.geneticliteracyproject.org/2016/04/05/studies-gmo-food-safety-length-matter/
By Andrew Porterfield (Apr 5, 2016)
Anti-GMO activists have long demanded that scientist extend the duration of animal studies to evaluate the risks of genetically modified food and feed. In 2013, writer Tom Philpott began hyping the now-discredited Gilles-Éric Séralini study on GM corn and rats in Mother Earth News, he framed the study as the “longest-running GMO study” (at two years)–which was not accurate. Later that year, Australian researcher and anti-GMO advocate Judy Carman released a study on pigs, this one clocking in at 154 days, and claimed that the longer-term study found differences in inflammation among pigs fed GM feed.
The actual data from both of these, and other, studies, does not actually support the claims of harm made by the authors. But that hasn’t stopped activists from demanding animal feeding studies of increasingly longer durations, even up to 30 years.
So how long is long enough? The industry standard for any safety analysis of a consumer product is 90 days. Would longer studies show anything that the industry standard wouldn’t? Are animal studies even necessary?
Currently, about 100 studies longer than 90 days have been conducted on GMO products in animals for risk assessment purposes–a sizable amount. Only the infamous Séralini and Carman studies have raised serious safety issues. The bulk of the studies on GMOs–more than 2000–are 90 days or shorter, in line with accepted international guidelines. But anti-GMO activists continue to suggest “no long term studies” have been done, and they demand even more than the 100+ that have been done so far. Mischa Popoff, a former organic farm inspector who is now with the Heartland Institute, wrote:
Organic activists used to predict that negative health impacts from consuming GMOs would be rather immediate, within a year or two, 10 years tops. But as more major crops were genetically modified and the overwhelming majority of farmers adopted them, and as the years drifted by, organic activists found themselves at a loss for an explanation. We began to hear demands for long-term, multigenerational studies from within organic circles.
And many animal studies may not even be valuable, or even scientifically justifiable. Bruce Chassy, professor emeritus of food safety and nutritional sciences from the University of Illinois and co-author of an International Life Science Institute (ILSI) paper that set standards for food safety research, questioned the validity of longer animal feeding studies:
Animal studies are weak, lack power and have no hypothesis. If you study 500 parameters you’ll find something different between test and control groups. The longer you study, the more likely you will see differences between them. If you just look at a lot of data, and try to correlate with something, you’re more likely to make a false correlation than a true one. The few studies by anti-GMO activists cite significant differences but not actual harm.
No long term studies?
Here is a partial list of dozens of studies longer than 90 days (more here) on GMOs–none of which have shown serious safety issues:
•Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: A literature review: We examined 12 long-term studies (of more than 90 days, up to 2 years in duration) and 12 multigenerational studies (from 2 to 5 generations). … The studies reviewed present evidence to show that GM plants are nutritionally equivalent to their non-GM counterparts and can be safely used in food and feed.
•A three generation study with genetically modified Bt corn in rats: Biochemical and histopathological investigation: This study was designed to evaluate the effects of transgenic corn on the rats that were fed through three generations with either GM corn or its conventional counterpart. Tissue samples of stomach, duodenum, liver and kidney were obtained for histopathological examinations. … No statistically significant differences were found in relative organ weights of rats within groups but there were some minimal histopathological changes in liver and kidney.
•Effects of long-term feeding of genetically modified corn (event MON810) on the performance of lactating dairy cows: A long-term study over 25 months was conducted to evaluate the effects of genetically modified corn on performance of lactating dairy cows. Thirty-six dairy cows were assigned to two feeding groups and fed with diets based on whole-crop silage, kernels and whole-crop cobs from Bt-corn (Bt-MON810) or its isogenic not genetically modified counterpart (CON) as main components. … Milk yield (23.8 and 29.0 kg/cow per day in the first and the second lactation of the trial) was not affected by dietary treatment. There were no consistent effects of feeding MON810 or its isogenic CON on milk composition or body condition. Thus, the present long-term study demonstrated the compositional and nutritional equivalence of Bt-MON810 and its isogenic CON.
•Organic and Genetically Modified Soybean Diets: Consequences in Growth and in Hematological Indicators of Aged Rats: There was an organic soy group (OG), a genetically modified soy group (GG), and a control group (CG). All animals received water and diet ad libitum for 455 days. At the end of this period, the weight of the GG group was the same as that of the OG, and both were higher than CG. Protein intake was similar for the OG and GG, which were significantly lower (p<0.0005) than the CG. The growth rate (GR) of the rats, albumin levels, and total levels of serum protein were comparable for all groups. Hematocrit (p<0.04) and hemoglobin (p<0.03) for the OG and GG were less than the CG. Although the OG and GG demonstrated reduced hematocrit and hemoglobin, both types of soy were utilized in a way similar to casein. This result suggests that the protein quality of soy is parallel to the standard protein casein in terms of growth promotion but not hematological indicators.
•Histochemical and morpho-metrical study of mouse intestine epithelium after a long term diet containing genetically modified soybean: In this study, we investigated the duodenum and colon of mice fed on genetically modified (GM) soybean during their whole life span (1–24 months) by focusing our attention on the histological and ultrastructural characteristics of the epithelium, the histochemical pattern of goblet cell mucins, and the growth profile of the coliform population. Our results demonstrate that controls and GM-soybean fed mice are similarly affected by ageing. Moreover, the GM soybean-containing diet does not induce structural alterations in duodenal and colonic epithelium or in coliform population, even after a long term intake. On the other hand, the histochemical approach revealed significant diet-related changes in mucin amounts in the duodenum. In particular, the percentage of villous area occupied by acidic and sulpho-mucin granules decreased from controls to GM-fed animals, whereas neutral mucins did not change.
What do the world’s top regulators require?
In 2013, the European Union required a 90 day rodent feeding study for every GE transformation that’s introduced in feed or food. However, the European Food Safety Authority (EFSA), which provides independent scientific advice to inform food safety in the EU, has stated that this kind of testing is needed only when a specific hypothesis needs to be tested, such as a change in molecular, metabolic pathway or phenotypic characteristic. The United States, New Zealand, and Australia do not require these feeding studies.
Recently, the EFSA clarified the data requirements for assessing the risks of GM plants in the EU. In that clarification, the agency stated that it does not require animal studies — of any length. Instead, the agency re-emphasized that it was interested in comparisons between GM and the equivalent conventional plant, including data on observable appearances, yield, and pesticide tolerance. Only if those comparisons indicate a possible hazard should more detailed studies to better understand the nature of the hazard and risk be required (i.e., a hypothesis-driven approach).
The Codex Alimentarius, which documents the rules for food safety established by the UN’s Food and Agriculture Organization (FAO), also calls for specific hazard assessment (i.e., identification of any chemical or allergen that may be present in the GM variety) but not for long-term, feeding studies.
The regulation of genetically modified food and feed is an exception in the consumer products world (outside of prescription drugs and pesticides, which are necessarily regulated quite differently). They are the only food (and one of the few consumer products) that is evaluated for risk before entering into the market. Conventional foods, including organic and those having undergone radiation or hybridization to produce certain traits, do not undergo this same testing in most places in the world (Canada being a notable exception).
Even for cosmetics in the United States, the U.S. FDA does not require animal tests unless searching for a suspected or known hazard. The FDA does issue guidelines on the use of rodent and non-rodent species (dogs) in toxicity studies, including studies that last more than a year, but these studies are hypothesis-driven evaluations of specific hazards. In the United States, government agencies have even urged testing for consumer products to be conducted in vitro, and to avoid the use of laboratory animals when possible.
Another 90 day study, same results
Just last month, the EU announced the results of a GMO Risk Assessment and Communication of Evidence (GRACE) 90-day feeding study of MON810 corn on rats. They also studied the rats for a year. The 90-day study didn’t produce anything that would have justified a longer-term study and the results of the one-year study corroborated the validity of that conclusion.
The study authors concluded:
Data collected by GRACE showed that non-targeted feeding studies could lead to randomly generated significant differences between animals fed with the GM test material and animals fed with a controlled diet. Such results are not informative for risk assessment.
As such, GRACE data supports the scientific reasoning that feeding trials with whole food / feed may provide an added scientific value for the risk assessment of GM crops, but only in case a trigger is available from the initial molecular, compositional, phenotypic and / or agronomic analyses.
With a re-evaluation of the safety and regulation of GM food about to begin in Europe, and the introduction of newer, “second generation” GM crops, food and feed starting to enter the regulatory and market pipeline, putting “long-term” into proper perspective has (almost) never been so important. We now have 17 years of data on existing food, with no documented adverse effects.
Is Terrorism a Threat to the U.S. Food Industry?
Source : http://www.foodsafetymagazine.com/blog/is-terrorism-a-threat-to-the-us-food-industry/
By Robert A. Norton, Ph.D.(Apr 5, 2016)
Is Terrorism a Threat to the U.S. Food Industry?
Last November, the Iraqi government feared that ISIS had stolen a device in Basra that contained dangerous radioactive material. The device in question carried approximately 0.35 oz. of the radioisotope iridium-192 (192Ir), which has a half-life of approximately 74 days and is capable of causing severe injury if people are exposed for minutes to hours, or even death if exposed for longer periods. If 192Ir were obtained by a terrorist group like ISIS, bad things could happen. Fortunately, the device was later found close to where it was stolen, indicating the theft was more likely an incidental criminal act, rather than an actual attempt by ISIS to acquire radioactive material. No link between this event and the terrorist group has yet been disclosed.
Thefts of similar devices carrying the same isotope are not new and have in fact occurred multiple times in multiple countries, including Mexico, where the latest happened in late February 2016, in San Juan del Rio, Mexico.
So what does this all have to do with the food industry? For one thing, the food industry should start thinking seriously about various terrorism-related scenarios that could potentially involve radioactive materials and make preparations for dealing with these situations should they become reality. The most immediate element of concern for a food facility—maybe a large production plant or sprawling warehouse—would actually be from the direct blast effects emanating from an improvised explosive device (IED) rather than from any radioactive material that might be present.
In other words, more people would likely be killed from the explosion than from direct effects of the radioactive material. Companies within the food industry need to look to themselves first for solutions to this type of potential scenario.
So what would ISIS gain from detonating an IED in one or more major U.S. food facilities, injuring or killing perhaps dozens of people and compromising the food supply? Destruction of critical infrastructures is believed to destroy the United States, so ISIS sees destroying the U.S. food industry as a means to an end—the end state being the destruction of the country. ISIS would like to facilitate that destruction by placing individuals inside the myriad critical infrastructures that make up the food industry. Food corporations must consider significant security events as a distinct possibility and prepare themselves for the consequences.
It is important to have perspective, however. I am not discounting the terrorist group’s ability to inflict injury and tragedy within the food industry, but it’s important to remember that while ISIS members are criminals, not all criminals are a part of ISIS. It’s important to strike a balance between being cognizant of terrorism as a potential threat to a food business and understanding that not all bad occurrences are the result of terrorists.
Making the food supply seem vulnerable, fostering panic buying, gains the attention of the press and creates more panic buying, resulting in a vicious loop of action and reaction. Even so, the United States and its allies are very skilled at developing intelligence to help protect the food supply and other industries, and then sharing it with allies that can affect solutions.
The bad news, however, is that leaders of terrorist organizations are aware of our rigorous, well-executed security plans—such as a food production plant’s perimeter security—so they are looking for alternate ways to penetrate critical infrastructure. This is where the discussion gets very sensitive and is best left unannounced in a public forum—suffice it to say that radioactive materials don’t have to enter the food supply through a bomb.
Will the food industry experience IEDs in the coming months? Probably not, but clearly there is no guarantee. The U.S. food industry must protect the integrity of our food supply by continuing to recognize the threats to food safety and develop appropriate countermeasures.
Robert A. Norton, Ph.D., is a professor at Auburn University and chair of the Food Systems Institute’s Biosecurity and Food Defense Working Group. A long-time consultant to federal and state law enforcement agencies, the U.S. Department of Defense and industry, he specializes in intelligence analysis, weapons of mass destruction defense and national security. For more information on the topic or for more detailed discussions about specific security-related needs, he can be reached at email@example.com or by phone at 334.844.7562.
A Tale of Food Safety Woes: This Ever Happen To You?
Source : http://www.foodsafetymagazine.com/enewsletter/a-tale-of-food-safety-woes-this-ever-happen-to-you/
By John T. Shapiro, Esq. (Apr 5, 2016)
A Tale of Food Safety Woes: This Ever Happen To You?
Most food companies work hard to take the proactive precautions and practical steps required by the Food Safety Modernization Act (FSMA) and other applicable laws and regulations to ensure that the food products they produce, package, transport, store or sell are safe for consumers to eat. Some companies, however, continue to ignore or, at times, let their guard down regarding, the good practices those laws embody. Others fail to adequately oversee the practices of supply partners. As a result, despite unprecedented education about and devotion of resources to food safety since enactment of FSMA in 2011, mistakes continue to happen, recalls proliferate and consumers continue to unknowingly face adulterated and misbranded food products.
For unwary and wary food companies alike, cautionary tales abound. Valuable lessons can be learned from the mistakes, intentional and unintentional, of others. Those accounts warrant telling and repeating.
Consider, for example, the recent fate of Sullivan Harbor Farm. In a 15-page complaint filed in federal court, the U.S. Food and Drug Administration (FDA) alleged that its investigation of the seafood processing plant uncovered numerous food safety deficiencies, including the processor’s failure to:
1. Implement a Hazard Analysis and Critical Control Points (HACCP) plan with sufficient controls to prevent known food safety hazards
2. Verify that controls used were effective
3. Monitor the controls
4. Maintain records reflecting the controls
5. Take corrective actions when practices failed to prevent food-safety issues
6. Handle food and packaging and sanitize surfaces in a manner that protected against contamination
This was not the first time that FDA had cited Sullivan Harbor Farm for food safety-related lapses. As a result, FDA requested that the Court enjoin further operations until Sullivan Harbor Farms agreed to clean its facility, implement an adequate HACCP plan and comply with other applicable laws and regulations to the satisfaction of FDA. In a 22-page consent decree entered on February 12, 2016, Sullivan Harbor Farm agreed to entry of an extensive injunction that provides that its future operations are contingent on completion of a comprehensive food safety overhaul, including retention of independent experts to oversee development and implementation of a new HACCP plan and other food safety-related systems.
The acts of others outside the four walls of your facility can cause a food company similar harm. The horse meat scandal in Europe continues to serve as a stark reminder of that lesson. Although that incident did not cause a widespread foodborne illness epidemic, it did cause consumer outrage, much less cause many to question how this could happen. The incident was all the more puzzling because it ensnared several large companies with well-known brands and sophisticated food safety regimens.
The answer to the quandary appears straightforward. Companies within that food supply chain did not adequately evaluate or oversee their direct supply partners or the suppliers of their partners.
Implementation of meaningful controls over internal operations and external supply chains is not easy. But there is no choice but to devote the time and effort to do so. Companies no longer can fly under the radar of governmental scrutiny, hoping that their practices and those of their partners will not be tomorrow’s bad news.
Stated otherwise, under the new food safety regime, the buck stops with each food company. It therefore is important that food companies take heed of the lessons that Sullivan Harbor Farm, the horse meat scandal and many other food adulteration or misbranding occurrences provide. The take away? Understand the laws, regulations, practices and protocols that govern your food-related business. And do the opposite of Sullivan Harbor Farm and the others who cut corners.
With respect to internal operations, companies must continually engage in proactive, realistic and ongoing assessment and action, including:
• Identification and analysis of known or reasonably foreseeable hazards that may cause adulteration or misbranding of food products
• Implementation of science-based measures to prevent or minimize the likelihood of the hazards identified
• Oversight of preventive controls to make sure that they are being carried out
• Verification designed to make sure that preventative controls are effective and up-to-date with technological advancements
• Corrective actions procedures to correct both isolated production problems and more systemic flaws with the preventative control systems
• Protection against intentional adulteration or misbranding
• Record review and record-keeping and access protocols
• A recall protocol in the event a problem occurs despite the other control.
Of course, even a well-designed food safety regimen may be fail without adequate buy-in from top management and well-trained employees who are able to implement all aspects of the plan.
Managing external relations requires that a company employ similar rigor in an effort to assess and understand with whom it is dealing and form strong, transparent relationships that meet its need, including:
• Conducting due diligence in preparation for the supply relationship, including assessment of the laws, regulations and protocols to which a the potential supply partner is subject to make sure that they mesh with the company’s needs
• Negotiating thoughtful supply agreements with precise terms
• Overseeing supply partners, including audits as needed of partner operations
• Building sufficient flexibility into the relationship to allow for change where needed to meet food safety obligations or other needs
• Retaining broad termination rights should the supply relationship fail to meet the company’s food safety obligations or other needs
Could this—the fate of Sullivan Harbor Farm or the companies that sold horse meat to unsuspecting consumers—happen to you? Perhaps it is probable for the unwary or to the company who believes it can ignore or skirt the law. But for companies who take heed of the valuable lessons the food safety mishaps of others provide, such a troubling result is unlikely.
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