Something fishy in genetically engineered salmon?

Members of Congress sent the FDA strongly worded, bipartisan letters calling on the agency to halt approval of a controversial genetically engineered (GE) salmon under review, according to the Center for Food Safety (CFS). This discussion began in earnest about a year ago when FDA released its briefing packet on the subject. FE’s Tech Flash covered the story on September 8, 2010.

“Members of Congress have once again raised the stakes in the GE salmon debate,” says Andrew Kimbrell, CFS executive director. “FDA simply cannot continue to ignore the growing calls to stop this misguided approval.”

The two letters were sponsored by Sen. Mark Begich (D-AK) and Rep. Don Young (R-AK) and joined by 21 members of the House and Senate. The letters remind FDA of an “ever-growing Congressional opposition” to the fish and call on the agency to shift priorities in light of the Young-Woolsey amendment that was included in the House-passed Agriculture Appropriations Act of 2012, which would bar FDA from using funds in the 2012 fiscal year to approve GE salmon, according to CFS.

Not so fast, say proponents of GE salmon. In a commentary piece published in the online version of Nature Biotechnology, animal scientists Alison L. Van Eenennaam of UC Davis and William M. Muir of Purdue University recap the regulatory review saga of AquAdvantage (AA) salmon, a fast-growing, genetically engineered salmon.

“Although the first genetically engineered animals were developed almost 30 years ago, none has been approved for food production,” says Van Eenennaam, a Cooperative Extension animal genomics and biotechnology specialist in UC Davis’ Department of Animal Science.

“The protracted evaluation of the AA salmon, and continuing uncertainties in the regulatory process and timeline, have essentially halted commercial investment in the development of genetically engineered animals for agricultural applications in the United States,” says Van Eenennaam, who served on the FDA’s Veterinary Medicine Advisory Committee, which was charged with reviewing a proposal to commercialize the AA salmon.

The AA salmon, developed by Aqua Bounty Technologies, carries a gene from Chinook salmon that speeds growth and improves feed efficiency in farm-raised fish. The fast-growing, genetically engineered salmon has been under federal regulatory review by FDA since 1995.

Opponents of the genetically engineered salmon have expressed concerns that the new GE fish might force the wild salmon population into extinction if they were to make their way into the wild, and could pose an increased allergy risk for consumers. Muir and Van Eenennaam counter that neither concern is substantiated by scientific data.

Muir lists several reasons why opponents’ thinking is wrong:

• Only triploid eggs (which have three copies of each chromosome) would be sent from production in a land-locked Canadian location to a farm in Panama. The eggs are 99.7 percent sterile, and all fish would be female, unable to breed with each other.
• The farm facility in Panama is land-based, with screens to keep the salmon inside. In addition, if fertile AA salmon were able to escape, they would perish when reaching water too warm for their survival. If fish could escape and survive, they would have to swim thousands of miles to find spawning streams and mates.
• Regarding allergens, there is no baseline for the amount of allergens a fish may contain before it is unsafe for human consumption, and some fish-such as herring-have significantly more allergens than AA salmon.

According to CFS, FDA currently approves GE animals through its new animal drug law, yet critics fault the process as failing to require adequate safety assessments and lacking transparency and public engagement. The decision to regulate GE animals as animal drugs was announced by FDA in 2009 in the form of a Guidance to Industry, a non-binding form of regulation.

Muir argues that FDA will treat AA salmon like a new drug that has been through the regulatory process. The agency can approve and continue to monitor the salmon. If new concerns are raised and found to be valid, the government could withdraw its approval, says Muir.

As the Food Safety Modernization Act (FSMA) begins to take effect, one of the first mandates to be enacted is “one up, one down,” which holds each company in the food manufacturing chain accountable for tracing all shipments from their suppliers to where each product is sold. The legislation also provides FDA with mandatory recall authority, eliminating the need to rely on the compliance of the food manufacturer, according to Tom Egan, vice president of industry services for PMMI.

“These additional tracing requirements will give food manufacturers the ability to quickly and effectively identify products in the event of a recall,” adds Egan. “But first, players in the food industry will need to update their equipment with the newest track and trace, data collection and serialization technologies.”

They can start by looking to the pharmaceutical industry and European food processors for insight into best practices, suggests Egan.

The increased proliferation of counterfeit drugs forced pharmaceutical manufacturers to implement standard operating procedures-including “one up, one down”-to validate production lines. Many of the technologies and processes involved, such as validation software, have crossover potential and could be adapted to bring the same level of sophistication and checking to the food supply chain, says Egan.

“The European Union (EU) implemented strict ‘one up, one down’ policies in reaction to the bovine spongiform encephalopathy (BSE) crisis of the late 1990s, culminating in the creation of the European Food Safety Authority,” adds Egan. “Additionally, a common food law enacted in the region in 2005 placed a strong focus on food safety at all steps along the production chain. Like FSMA, the law outlines traceability programs aimed to quickly implement recalls, putting the obligation on food manufacturers to be more diligent in their tracking.”

In addition to the latest food safety innovations, food manufacturers attending PACK EXPO Las Vegas 2011 (September 26-28, Las Vegas Convention Center) will find resources for complying with FSMA mandates. Track-and-trace technologies will be a focus, and attendees will have also access to pharmaceutical technologies that can be adapted to food applications at the new Pharmaceutical Pavilion. This special hub will feature exhibitors showing the newest data collection technologies and innovations to address safety and security, product protection and anti-counterfeiting.

PACK EXPO Las Vegas 2011 resources also include The Food Safety Summit Resource Center, where attendees can learn about the latest breakthroughs in food safety and gain valuable insight into potential solutions from leading industry and subject matter experts. The center is hosted by BNP’s Food Safety Summit. In addition, the Conference at PACK EXPO will present several relevant sessions, including “The A to Z Cookbook of Implementing an Effective Serialization Program” on Monday, Sept. 26 from 3:15-4:15 pm.

Discounted registration is available at Packexpo.com through Sept. 7. Passes purchased on or before Sept. 7, 2011 are $30.00 and increase to $60.00 on Sept. 8. Registration for Conference at PACK EXPO sessions can be done simultaneously. A discounted rate of $99 per session will be charged on or before Sept. 7, 2011. After that date, registration will be $125 per session.

For more information about PACK EXPO Las Vegas 2011 or to register, visit www.packexpo.com or contact PMMI’s Show Department at 703-243-8555 or expo@pmmi.org.

Labels for food products-especially canned soup, coffee creamer and aerosol non-stick sprays-underestimate the calories, sodium and saturated fat consumers are likely to get from these products, since the recommended serving sizes are much smaller than actual serving sizes consumers eat, according to the Center for Science in the Public Interest (CSPI). In a letter to FDA, CSPI urged the agency to revise its serving-size regulations.

Canned soup presents a dramatic example of how unrealistic the stated serving sizes are, according to CSPI. Labels for a particular chicken noodle soup indicate a serving size of one cup (a little less than half a can) has 790mg of sodium-a hefty amount by any standard and about half the sodium most adults should consume daily (American Heart Association revised numbers). But according to a CSPI national telephone survey, 64 percent of consumers said they would eat the whole can at once, consuming 1,840mg of sodium, more than a day’s worth for most adults. CSPI found similar results for other soups such as reconstituted tomato soup.

The serving size for ice cream is a dainty half-cup, and nutrition facts labels for Häagen-Dazs vanilla ice cream dutifully list 10 grams of saturated fat per serving. So someone eating a whole cup of that ice cream would actually be eating a full day’s worth of saturated fat (20g), according to CSPI.

“Given the prevalence of hypertension, heart disease and stroke in America, we need accurate food labels that would ensure that consumers really know what they’re likely to consume,” says CSPI Executive Director Michael F. Jacobson. “The FDA should define serving sizes to reflect what consumers actually eat, as the law requires, not what the soup industry pretends that they eat.”

There are certain applications in the food industry where it’s impractical to close a physical door as we know it-yet it’s still necessary to maintain environments on both sides, e.g., keep temperatures consistent and the bugs out. A special class of doors can do this-be open and closed at the same time-because they consist of an invisible, fast-moving sheet of air powered by special fans to keep different environments separate from each other.

Called “air curtains” or “air doors,” they can be used in conjunction with operational doors-either high-performance fabric roll-ups or more conventional solid refrigerator or freezer types-or on their own between a doorway or a pass-thru window.

“They do a great job in protecting a building’s inside environment from windborne dust, dirt, fumes and flying insects, while separating areas of temperature and pressure differential,” says Steve Rosol, president of Mars Air Systems of Gardena, CA. “They can also help save money by preventing conditioned air from escaping through open doors.” Mars Air provides a wide range of air curtains that achieve an average payback within two to two-and-a-half years.

In food processing applications, air curtains are particularly effective when used with solid doors in high-traffic areas. During production, the solid door can be kept open, enabling people and equipment to move through freely, allowing the air curtain to separate the two environments. At night, when production is over, the solid door closes for full separation (e.g., in a freezer or cooler scenario), and the air curtain shuts down. 

Other important food-related capabilities include washdown units that can take hose-directed water without shock hazard, explosion-proof construction useful in grain or flour mills, and heated units for applications that require enhanced comfort for employees or customers, either while walking through or working in close proximity to the unit’s discharged air stream. 

“About 40 per cent of our customers require heat, and we provide four options for heating the air: steam, hot water, electricity and natural gas,” notes Rosol. He adds the trick in designing and installing an air curtain system is to find the “sweet spot” where the volume, temperature and speed of the air stream is just right for the specific opening. “No two solutions are the same, requiring Mars to work closely with the customer to get each one exactly right.”

For more information, contact Steve Rosol, 800-421-1266, info@marsair.com

Bolletje, a Dutch baked goods manufacturer with 500 employees and three plants in the Netherlands, needed to solve a production issue: variation in the quality of its dough from batch to batch due to inconsistent process execution. The company turned to long-time partner, GE Intelligent Platforms, for a solution that would help the baker not only improve quality, but also achieve better insight into inventory and provide a method of tracing its products from the bakery to the store.

The selection and implementation of the Proficy solution was initially driven by the company’s information technology group that was looking for an integrated implementation with one interface and easy, actionable access to information. As the potential gains became clearer, the production group took on overall project management and engaged additional stakeholders. Management’s goal was to make sure it could bring new operators on board quickly and efficiently without a loss in productivity or quality. Shift leaders wanted less waste and more throughput.

The baker started the implementation of the software with a small production line that primarily produced the dough for specialty seasonal- and holiday-themed products, and then expanded to three additional lines that were involved in making dough for pretzels. Working with Novotek, GE’s partner in the Netherlands, Bolletje chose the Proficy software platform because it provided an integrated system for batch execution, MES automation and visualization. The combination of Proficy iFIX, Historian and Plant Applications became the standard manufacturing platform for Bolletje, giving the company better control and visibility into the whole manufacturing process.

In 2010, the company introduced the Proficy solution as it installed new production lines used for baking crispbreads (crackers) and rusks (biscuits). The software made data collection much easier, enabling capitalization of performance information obtained from the production lines.

In addition to quality, Bolletje’s plans include improving inventory accuracy. The current system is based on an accounting practice called backflushing, where the company accounts for material usages based on counts of finished product. This approach can drive incorrect scheduling and production decisions. The company plans to obtain more visibility into the actual use of raw materials to improve materials planning, and get more accurate understanding of material costs for each product line. With the software’s integrated solution, inventory accuracy can be achieved while also enabling end-to-end traceability of ingredients, processing conditions and quality data-all linked to each production lot.

“We are still implementing elements of the solution, so the full results are a bit down the road. But already, shift leaders are very enthusiastic about the solution,” says B-J Hudepohl, Bolletje production manager. “They see less waste, and new workers are being trained faster, ensuring the expertise of seasoned operators is captured. In fact, there has only been one bad batch of pretzels since the system was installed on that line.”

For more information on GE Intelligent Platforms solutions for food and beverage companies, visit the food and beverage website.

Growing rapidly from humble beginnings in 1995, Dogfish Head is one of the largest craft breweries in the mid-Atlantic region and now brews more than 34 unique beers sold in 27 states. The company recently added more brewing equipment to increase its daily brewing capacity from 700 barrels to 900 barrels. With such growth and new equipment, the brewery realized the need for a robust enterprise asset management/computerized maintenance management system (EAM/CMMS) solution.

Dogfish Head had been using a home-grown, work request system a featuring combination of paper and spreadsheets, but the system didn’t allow the staff to schedule preventive maintenance tasks or track history and maintenance operations costs. Dogfish Head Maintenance Manager John Wren realized the need for a maintenance management system when he came on board in July 2010. He had heard about TabWare through various trade publications and AssetPoint white papers.

After evaluating several EAM/CMMS solutions, the brewer chose TabWare from AssetPoint to manage its assets and maintenance. Dogfish Head then implemented TabWare to track and manage all aspects of its operations including production and packaging equipment, which directly affects company revenue. The software also allows Dogfish Head to create a preventive maintenance system, where routine maintenance can be scheduled and ensure the right people, parts and documentation to do the work safely and efficiently are in place.

“In our business, we can’t afford to have downtime because it affects the quality of our product,” says Wren. “If our production lines go down, we have to throw away beer. As we evaluated various EAM solutions, we chose TabWare because it is truly easy to use, and provides us with the data necessary to maximize productivity, eliminate unplanned downtime of our equipment and make us more energy-efficient as an environmentally conscious company.”

For more information, visit AssetPoint’s website and the TabWare page.

The HART Communication Foundation, Fieldbus Foundation and PI (Profibus and Profinet International) have joined forces to create an architecture for a new WirelessHART gateway device. The device allows a WirelessHART network of devices to communicate bi-directionally with a host automation system via the Fieldbus Foundation High Speed Ethernet (HSE) protocol or the PI protocol, Profibus.

When completed, the architecture and its related specification provide a standard structure for others in the industry to design and build the gateway device. The specification covers the three primary functions needed for the integration: gateway configuration, wireless sensor configuration and system operation.

Gateway configuration is performed by the gateway engineering application in the host automation system. This application uses client/server communications over HSE or Profibus to configure the I/O mapping of the wireless sensor parameters (such as device address, device tag, process variables, process alarms and other data) into database objects. Once the gateway is configured, the wireless sensor engineering application is used to bring the wireless sensors online. Once the gateways and the wireless sensors are configured, normal system operation can begin. The gateway will scan through its list of wireless devices and request each device to send its parameter data to the gateway.

For more information on the the system, visit the HART Communication Foundation website.

University of Minnesota researchers have discovered and received a patent for a naturally occurring lantibiotic-a peptide produced by a harmless bacteria-that could be added to food to kill harmful bacteria like Salmonella, E. coli and Listeria.

The U. of M. scientists say this lantibiotic is the first natural preservative found to kill gram-negative bacteria, typically the harmful kind. “It’s aimed at protecting foods from a broad range of bugs that cause disease,” says Dan O’Sullivan, U. of M. professor of food science and nutrition. “Of the natural preservatives, it has a broader umbrella of bugs that it can protect against.”

The lantibiotic could be used to prevent harmful bacteria in meats, processed cheeses, egg and dairy products, canned foods, seafood, salad dressing, fermented beverages and many other foods. In addition to food safety benefits, lantibiotics are easy to digest and nontoxic, do not induce allergies and are difficult for dangerous bacteria to develop resistance against.

O’Sullivan discovered the lantibiotic by chance, while researching the genome of bacteria. He then collaborated with Ju-Hoon Lee, a U. of M. graduate student, to continue the research. The U. Of M.’s Office for Technology Commercialization is currently seeking a licensee for the technology.

Recent E. coli and Salmonella recalls emphasize the importance of finding new and harmless-to-human bacteria killers. “Salmonella burden has increased more dramatically than any other foodborne illness,” says Shaun Kennedy, director of the National Center for Food Protection and Defense. “The largest recall in 2010 for food contamination was eggs contaminated with Salmonella.”

Salmonella and E. coli, both gram-negative bacteria, account for more than half of all food recalls in the United States. According to the Centers for Disease Control and Prevention, Salmonella contributes to an estimated 28 percent of the more than 3,000 deaths related to foodborne illness each year.

UL (Underwriters Laboratories) announced the launch of UL Food Safety, a new program dedicated to addressing the growing needs of the global food industry by promoting standards-based safety solutions.

UL Food Safety will help mitigate risk by employing science-based processes to help address industry concerns, new government regulations and heightened consumer awareness of food safety issues. The new offering builds on UL’s 117-year history of advancing public safety through the creation of actionable solutions beginning with a training curriculum through UL University. The training program is the foundation for a larger portfolio of services under development including traceability, validation and testing services.

UL Food Safety is launching the training platform with the first of three courses, “Food Safety Culture,” which is designed to guide food industry executives through the process of creating an organizational culture to ensure food products are safe and meet consumer and regulatory requirements. It also establishes a framework for corporate management responsibility, communication of food safety objectives to all company employees and continuous improvement in Hazard Analysis & Critical Control Points (HACCP) and overall food safety systems. 

“HACCP is a step in the right direction, but it is not the final destination. It is up to the leadership in the food industry to create a culture of food safety as well as to keep up with the science,” says Frank Yiannas, vice chair of the Global Food Safety Initiative (GFSI) and author of the book, Food Safety Culture: Creating a Behavior-based Food Safety Management System.

The UL Food Safety training program will include succeeding courses on “Food Safety Awareness,” which provides actionable information to empower and equip food industry workers to the “first line of defense” in food safety, and “Evaluation of HACCP & Food Safety Preventative Control Programs,” which provides mid-level management and auditors with the practical knowledge to make effective decisions in critical situations. Both programs will be available Fall 2011.  

For more information on UL’s Food Safety services and to register for the “Food Safety Culture” course, visit http://www.ul.com/foodsafety.

The US Food and Drug Administration announced that Alpharma, a subsidiary of Pfizer Inc., will voluntarily suspend US sales of the animal drug 3-Nitro (Roxarsone), a product used by poultry producers since the 1940s. (For more on Roxarsone, see Tech Flash, Volume 5, No. 23.)

The move follows a recent FDA study of 100 broiler chickens that when tested showed inorganic arsenic, a known carcinogen, at higher levels in the livers of chickens treated with 3-Nitro compared with untreated chickens. FDA officials stress that the levels of inorganic arsenic detected were very low, and that continuing to eat chicken while 3-Nitro is suspended from the market does not pose a health risk.

“FDA detected increased levels of inorganic arsenic in the livers of chickens treated with 3-Nitro, raising concerns of a very low but completely avoidable exposure to a carcinogen,” says Michael R. Taylor, FDA deputy commissioner for foods. “We are pleased to announce that the company is cooperating with us to protect the public health.”

Published scientific reports have indicated that organic arsenic, a less toxic form of arsenic and the form present in 3-Nitro could transform into inorganic arsenic. In response, scientists from the FDA’s Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition developed an analytical method capable of detecting very low levels of inorganic arsenic in edible tissue.

Alpharma decided to voluntarily suspend sale of 3-Nitro and to facilitate an orderly process for suspending use of the product in the US. Alpharma’s plan provides for continued sales of 3-Nitro for 30 days from today. The company stated that allowing sales for this period will provide time for animal producers to transition to other treatment strategies and will help ensure animal health and welfare needs are met.

FDA has consulted with the US Department of Agriculture and is working with Alpharma to minimize the impact on the animal agriculture industry as 3-Nitro is suspended from the market.

“We applaud Pfizer’s voluntary step,” says Paige Tomaselli, staff attorney with the Center for Food Safety, “but we urge the FDA to now move forward on banning all arsenic-containing additives in animal feed. These include Pfizer’s own feed additives containing nitarsone, another arsenic compound, as well as those containing arsanilic acid and carbarsone. Clearly, producers can do without them, and they pose a very real threat to public health.”

For more information:
FDA Study on 3-Nitro (Roxarsone) and Chicken
FDA: Questions and Answers Regarding 3-Nitro (Roxarsone)

The Institute for Agriculture and Trade Policy, 2006 report: Playing Chicken: Avoiding Arsenic in Your Meat, David Wallinga, MD.