FDA denies petition against prophylactic use of antibioitics

The FDA rejected a 1999 petition and denied a 2005 petition to ban non-medical uses of antibiotics in animals. The petitions were submitted by the Center for Science in the Public Interest (CSPI) and involve the use of antibiotics in food-producing animals for growth promotion and feed efficiency considerations in production operations. FDA states it already has guidance in place discouraging prophylactic use of antibiotics in animals, making further rules unnecessary.

But according to Michael Jacobson, CSPI executive director, draft guidance or “draft discouragement” doesn’t really go far enough in putting a stop to antibiotic misuse. CSPI’s intent was to have FDA create a rule banning the practice of the prophylactic use of antibiotics in food animals. “FDA thinks its approach of cooperating with industry would be more efficient than going through a rulemaking process.” Jacobson says Congress is considering legislation, and FDA could adopt a regulation, but probably neither will happen.

According to FDA, the CSPI petition requests the FDA Commissioner to “rescind already approved, sub-therapeutic uses of medically important antibiotics in livestock feed.” The petition alleges the drugs are unsafe under the Federal Food, Drug and Cosmetic Act when used for sub-therapeutic purposes in animal agriculture because such use can drive the selection and transfer of antibiotic resistance in human pathogens, thereby compromising the effectiveness of antibiotics for treating infections in humans.

The petition requests the FDA Commissioner to “rescind approvals for sub-therapeutic uses in livestock of any antibiotic used in (or related to those used in) human medicine.” The petition further states that the FDA “should take action now to rescind approvals for sub-therapeutic uses in livestock of any antibiotic used in (or related to those used in) human medicine.”

FDA further stated in its rejection letter: “It is not entirely clear to us whether the action [CSPI is] requesting is for the FDA Commissioner to issue an order now withdrawing approval or whether [CSPI] instead is asking that formal withdrawal proceedings be initiated.”

In the first case (to issue an order now withdrawing approval of antibiotics), FDA indicated a formal evidentiary process must be followed before new animal drug approvals may be withdrawn, and the FDA cannot withdraw approval of a new animal drug until the legally mandated process is complete.

In the second case (initiation of withdrawal proceedings), FDA stated it has not decided to institute formal withdrawal proceedings at this time and is instead currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.

According to FDA, it already proposed in Draft Guidance #209 (The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals) two principles ensuring the careful use of antibiotics in food-producing animals. The first suggests the use of antibiotics be limited to those uses that are considered necessary for assuring animal health. The second principle suggests antibiotics be limited to those uses that include veterinary oversight or consultation.

CSPI doesn’t think the existing guidance is enough and that non-therapeutic antibiotic usage in animals is not prudent. “We are disappointed that, after 12 long years, the FDA rejected our petition and a more recent petition to ban non-medical uses of antibiotics in animals,” says Jacobson. “The industry’s irresponsible use of antibiotics in livestock increases the prevalence of antibiotic-resistant pathogens, and those germs can cause infections in humans that are difficult or impossible to treat. The industry has long failed to cooperate voluntarily, and the FDA should take binding action. Consumers cannot afford another decade of delay.”

The Institute of Food Technologists (IFT) will host its first Food Policy Impact Conference in Washington, DC at the Sheraton Crystal City. Scheduled for December 1, 2011, the conference will bring together professionals in food laws, regulations and policy to learn approaches that will make a tangible impact on the future.

“From a global perspective, establishing food regulations and standards is critical to ensuring the safety and quality of our food supply,” says Roger Clemens, IFT president. “This conference addresses crucial governmental efforts through regulatory interpretation, analysis of emerging issues and realistic assessments of the impact of policy on the food industry.”

The opening session will feature Michael R. Taylor, JD, FDA deputy commissioner, and Jenny Scott, senior advisor to the director of the Office of Food Safety at FDA’s Center for Food Safety and Applied Nutrition, who will provide key updates on the Food Safety Modernization Act.

Two separate conference tracks will be offered. One focuses on food safety and the other on food labeling and marketing. Attendees can either attend sessions within one track to focus on their experience, or move between tracks to gain a broader perspective on the issues.

The conference will feature a variety of speakers in both tracks including Scott Davis, Panera Bread chief concept officer; Craig Wilson, vice president, general merchandising manager of Costco Wholesale Quality Assurance and Food Safety; Richard Cleland, Esq., assistant director, Division of Advertising Practices, Federal Trade Commission (FTC); David Acheson, MD, managing director, Food & Import Safety, Leavitt Partners; and Barbara Schneerman, PhD, director, Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA.

The conference will close with a discussion between Michael Jacobson, executive director for the Center for Science in the Public Interest, and Peter Barton Hutt, senior counsel, Covington & Burling LLP, who will discuss the pros and cons of the current health, wellness and safety policies and regulation.

For more details, visit the advance program link http://bit.ly/sF7ORW.

According to the Material Handling Industry of America (MHIA) and the Automation Technologies Council (ATC), the Automate Show and Conference will again collocate with ProMat in 2013. Both exhibitions will be held January 21-24, 2013 at Chicago’s

McCormick Place

.

 ProMat is a material handling and logistics show held in North America, and Automate 2013 is an event for robots, vision, motion control and related automation solutions in North America. The combined program is designed to help end-users find solutions to their manufacturing and supply chain challenges.

“The decision to collocate ProMat 2013 and Automate 2013 was an easy one after the successful collocation of these events in 2011,” says George Prest, MHIA chief operating officer. “The collocation of Automate with ProMat 2013 will allow manufacturing, distribution and supply chain professionals unparalleled education and networking opportunities as well as exposure to the largest equipment and technology display of any show of its kind in North America.”

The collocated ProMat 2013 and Automate 2013 are expected to be larger than 2011’s event. More than 825 exhibitors are expected to showcase their solutions to some 30,000 professionals from more than 100 countries in industries such as warehousing/distribution, automotive, alternative energy, consumer goods, food and beverage, electronics, lab automation, medical, pharmaceutical, plastics, printing, security, semiconductors and more.

MHIA is an international trade association that has represented the material handling and logistics industry since 1945. ATC is the umbrella group for Robotic Industries Association (RIA), Automated Imaging Association (AIA) and Motion Control Association (MCA). RIA, AIA and MCA combined represent approximately 625 automation manufacturers, component suppliers, system integrators, end-users, research groups and consulting firms throughout the world. Automate was formerly The International Robots, Vision & Motion Control Show and dates back to 1977 when it began as the ROBOTS show. It is held every two years and showcases solutions for companies looking to use automation to be stronger global competitors.

While statistics recently showed that the Earth’s population is 7 billion people, by 2050, the population is expected to be 9 billion, and world governments’ focus is on methods to increase food production. According to Jim Harkness, IATP (Institute for Agriculture and Trade Policy) president, the technology required to feed the world isn’t as much of an issue as how our global agricultural markets are constructed. Harkness recently addressed the National Food Policy Conference, organized by Consumers Federation of America.

There are about a billion undernourished people today-far more than there were 30 years ago. But, according to the UN Food and Agriculture Organization (FAO), we produce 17 percent more calories per person today than we did 30 years ago, and far more than enough for everyone on the planet to have plenty to eat, says Harkness.

Harkness points out that besides 1 billion undernourished people, there are 1 billion people worldwide who are obese. “This is a market failure and policy failure, not a lack of production,” he adds. “If we don’t get to these systemic challenges, it’s not going to matter much how much food we can produce in 2050-many more than a billion will be left behind.”

In his presentation, Harkness listed seven systemic challenges to the global food system and how they will need to be fixed. They are in abbreviated form:

1. We have to address global poverty. We cannot separate the global food economy from rest of the global economy.
2. We have to acknowledge the crushing effect two decades of trade liberalization has had on food security.
3. Financial deregulation has created chaos in agriculture markets.
4. We must have serious climate change policy that reduces emissions and supports climate-resilient agriculture.
5. We need to support the ability of food-insecure countries to build-and in many cases rebuild-their own food systems.
6. Just as we need to integrate climate-resilience into our agriculture systems, we also need to integrate public health into our food system.
7. Finally, we are going to need a much more effective and democratic system of global institutions.

“The message that policymakers have so far failed to hear is that we have to create policies that recognize food not just as a tradable commodity but as a basic necessity for survival-policies that give individuals, communities and nations more control over where their food comes from,” concludes Harkness.

To read Harkness’ presentation in its entirety, visit the IATP website or download a PDF version.

The US government, World Bank and private sector partners announced plans to create a first-of-its-kind global fund to improve food safety worldwide at the Asia Pacific Economic Cooperation (APEC) summit in Hawaii. Waters Corporation, Mars Inc. and the US Agency for International Development (USAID) have jointly pledged $1 million to get the Global Food Safety Capacity Building fund off the ground. The fund will be managed by the World Bank and support global food safety improvements through expanded understanding of food safety standards and best practices throughout the food safety system, from farm to fork.

Food and waterborne diseases are leading causes of illness and death in developing countries, with a mortality rate of some 2.2 million each year, mostly children. The ultimate goal of this fund is to improve global public health, facilitate food trade and improve food security.

Based on the tripartite partnership pioneered by the APEC Food Safety Cooperation Forum, the fund will leverage the World Bank’s global reach to improve public health, including in developing countries in Africa, South Asia, East Asia and Pacific, Latin America and Caribbean, and the Middle East. It will encourage local stakeholders to invest in food safety capacity building through three pillars:

1. Developing, testing and validating pilot programs in APEC that will result in reproducible training modules that can be customized and rolled out across the globe. These programs would focus on issues including: supply chain management, food safety incident management, laboratory competency, risk analysis and food safety regulatory systems.
2. Addressing high priority food hazards, such as the highly poisonous and cancer-causing fungal aflatoxins in grain (25% of all agricultural production is affected); contaminants and pathogens such as Salmonella, Listeria, and toxic strains of E. coli, on meats, fruits, and vegetables; and viral and bacterial pathogens in seafood.
3. Strengthening Analytics and Metrics, including laboratory competency and the evaluation of the performance of food safety systems.

Speaking at the summit were Sri Mulyani Indrawati, managing director, World Bank; Frank Mars, president, Mars Symbioscience; Rohit Khanna, vice president worldwide business, Waters Corporation; Nancy Lindborg, assistant administrator, USAID; and Pamela Bailey, CEO, Grocery Manufacturers Association (GMA).

“Food and beverage companies have a vast amount of experience, knowledge and understanding when it comes to developing and manufacturing safe products,” says GMA’s Bailey. “We know what works, what doesn’t work and how to apply best practices along the entire global supply chain to ensure our products are safe. This fund will allow us to share our skills and technical expertise in food safety on a much broader scale.”

Begun three years ago as an industry-driven, research and development project sponsored by the European Commission, the WheyLayer project has found a suitable whey protein-based packaging replacement barrier film layer for non-recyclable, synthetic-based film products.
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Efficiency was built into Frito-Lay’s Casa Grande plant a quarter-century ago, but the snack maker takes the facility’s energy- and water-conservation systems to a new level with near net zero.
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Polymer science presents food and beverage manufacturers with many floor covering options, but performance often hinges on the expertise of the people installing them.
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Energy audits and management can increase the bottom line, but to be effective, the job is never done.
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Tumble-turn-cut-fold mixing action yields 100% batch uniformity in less than three minutes.
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Santa Monica Seafood recently received Food Safety System Certification (FSSC 22000). The certification was granted by Det Norske Veritas (DNV), an internationally recognized ISO certifying body.

 

Sara Lee Corp. announced the appointment of Ingrid Baron as chief marketing officer of its International Beverage business.

 

The Food Processing Suppliers Association reported 12,732 registered attendees for PROCESS EXPO 2011, which took place from November 1-4, 2011 at

McCormick Place

in Chicago. International attendees at this year’s event totaled just over 14 percent of visitors, with the largest delegations coming from Canada, Mexico, Colombia, Venezuela and Germany.

 

Industrias Bachoco S.A.B. de C.V., Mexico’s leading producer and processor of poultry and other food products, acquired American poultry company, O.K. Industries, Inc. 

 

GEA Process Engineering purchased an existing high-shear mixing technology called Mixing Formula. The new mixing business will be headquartered at GEA Skanderborg in Denmark.

 

Cargill and BASF Plant Science will co-develop a canola oil that will provide a dietary source of EPA/DHA. 

 

Dover Corporation acquired Advansor A/S. Advansor will become part of Hill PHOENIX, an operating company within Dover’s Engineered Systems segment. Based in Denmark, Advansor specializes in the design and manufacture of HFC-free, CO2 transcritical refrigeration and heat pump systems.

 

Subject to regulatory approval, Thailand’s largest chemical producer, PTT Chemical Public Company Limited, is investing $150 million in NatureWorks, a bioplastics manufacturer previously wholly owned by Cargill.

 

Evamor Natural Artesian announced a partnership as the official water sponsor of HealthCorps, founded by Dr. Mehmet Oz. Evamor and HealthCorps have joined forces to deliver their message of a healthy diet and active lifestyle in more than 41 schools in 11 states.

 

B&B Electronics, provider of rugged wireless connectivity and communication solutions, completed its acquisition of the assets of Quatech, Inc., a manufacturer of high-performance device networking and connectivity solutions.

 

New plant construction project activity in October for the food and beverage industry shows a 51 percent increase in expenditures compared to the previous month, according to research from Industrial Info. Expenditures for October totaled $1.27 billion from 87 new projects, while September’s new project count was the same, with a combined value of $840 million. Capital expenditures tallied 68 projects worth approximately $1.2 billion, while maintenance expenditures were a mere $40 million spread across 19 projects.