Posts Tagged ‘Food’

Genetically Engineered Animals

Sunday, February 8th, 2009

FDA approves 1st drug from genetically altered animals

FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder

The U.S. Food and Drug Administration today issued its first approval for a biological product produced by genetically engineered (GE) animals.

The approval is for ATryn, an anticoagulant used for the prevention of blood clots in patients with a rare disease known as hereditary antithrombin (AT) deficiency. These patients are at high risk of blood clots during medical interventions, such as surgery, and before, during and after childbirth.

ATryn is a therapeutic protein derived from the milk of goats that have been genetically engineered by introducing a segment of DNA into their genes (called a recombinant DNA or rDNA construct) with instructions for the goat to produce human antithrombin in its milk. Antithrombin is a protein that naturally occurs in healthy individual and helps to keep blood from clotting in the veins and arteries.

GTC Biotherapeutics, Inc., the manufacturer of ATryn, received approvals from two FDA centers. The Center for Biologics Evaluation and Research (CBER) approved the human biologic based on its safety and efficacy, and the Center for Veterinary Medicine (CVM) approved the rDNA construct in the goats that produce ATryn.

“This product offers an important new treatment option for patients with hereditary antithrombin deficiency, preventing life-threatening clots that otherwise frequently occur during high risk situations,” said Jesse Goodman, M.D., M.P.H., CBER director.

Because hereditary AT deficiency occurs in a small population (approximately 1 in 5,000 people in the United States), the FDA granted ATryn an orphan drug designation. The orphan drug designation system encourages the development of medications for patients with a rare disease or condition.
The agency held an advisory committee meeting in January to seek the opinion of outside experts, who agreed that ATryn is safe and effective. CVM also briefed the committee about the animal drug components of the application.

Hereditary AT deficiency generally is first recognized and diagnosed in teenagers or young adults when they develop clots in their blood vessels, particularly during pregnancy, surgery, or prolonged bed rest.

CBER evaluated two studies that included 31 patients with hereditary AT deficiency who received ATryn to prevent thromboemboli (TE) before, during or after surgery or childbirth. All but one patient had a prior history of at least one TE, which are likely to recur in high-risk situations if left untreated. Only one of the 31 patients treated with ATryn developed a TE. The most common adverse reactions reported were hemorrhage and reactions at the infusion site. These reactions occurred in approximately five percent of patients.

As part of its review of the GE goat, CVM assessed the safety of the rDNA construct to the animals, including a full review of the construct and its stability in the genome of the goats over seven generations. No adverse outcomes were noted. CVM reviewed and concurred with the sponsor’s plan to continue to monitor the construct and its expression for the lifetime of the approved product.

During its review, CVM determined that introduction of the rDNA construct did not cause any adverse outcomes to the health of the goats over seven generations. CVM also determined that the manufacturer, GTC, has adequate procedures in place to ensure that food from these goats does not enter the food supply. As part of the approval, CVM specified that these goats cannot be used for food or feed and validated a method suitable for identifying the rDNA construct in both animals and their products.

As required by the National Environmental Policy Act and its implementing regulations, CVM also determined that the GE goats do not cause any significant impact on the environment.

“We have looked carefully at seven generations of these GE goats; all of them are healthy and we haven’t seen any adverse effects from the rDNA construct or its expression. I am pleased that this approval makes possible another source of an important human medication,” said Bernadette Dunham, D.V.M., Ph.D., CVM director.

A summary of the information on which the FDA made its approval decision for the rDNA construct in the goats, and CVM’s guidance on the regulation of GE animals containing heritable rDNA constructs are available at .

ATryn previously received approval from the European Medicines Agency for use in preventing clotting conditions during surgical procedures in patients with hereditary AT deficiency.

ATryn is manufactured by GTC Biotherapeutics, Inc., Framingham, Mass.

EPA Seeks Advice on Perchlorate in Drinking Water - Agency Issues Interim Health Advisory

Tuesday, January 13th, 2009

Release date: 01/08/2009

Contact Information: Enesta Jones, (202) 564-4355/7873/

(Washington, D.C. – Jan. 8, 2009) The U.S. Environmental Protection Agency is seeking advice from the National Academy of Sciences (NAS) before making a final determination on whether to issue a national regulation for perchlorate in drinking water.

The agency also is issuing an interim health advisory of 15 parts per billion (ppb) to assist state and local officials in addressing local contamination of perchlorate in drinking water and making a corresponding change to the factors it considers in cleaning up Superfund sites. States have the right to establish and enforce drinking water standards, and EPA encourages state-specific situations to be addressed at the local level. EPA expects to issue a final health advisory concurrent with the final regulatory determination for perchlorate.

“This is a sensible step for protecting public health and preserving regulatory options as the science of perchlorate is reviewed,” said Benjamin H. Grumbles, EPA’s assistant administrator for water.

On Oct. 10, 2008, the agency issued a preliminary regulatory determination for public comment in the Federal Register. The notice described the agency’s decision that there is not a “meaningful opportunity for health risk reduction” through a national drinking water regulation for perchlorate. The agency received more than 32,000 comments on the notice.

After considering public comments, as well as recommendations from EPA advisory groups and offices, EPA is asking the NAS to provide additional insight on various issues. Specifically, EPA is asking the NAS to evaluate its derivation of the Health Reference Level of 15 ppb, the use of modeling to evaluate impacts on infants and young children, and the implication of recent biomonitoring studies. The agency is also asking the NAS how it should consider the role of perchlorate relative to other iodide uptake inhibiting compounds and if there are other public health strategies to address this aspect of thyroid health.

EPA is replacing the existing preliminary remediation goal of 24.5 ppb with the interim health advisory value of 15 ppb. This goal will be used as a consideration when establishing cleanup levels for perchlorate at Superfund sites.

A regulatory determination is a formal decision by EPA as to whether it should initiate development of a national primary drinking water regulation for a specific contaminant under the Safe Drinking Water Act. EPA has drinking water regulations for more than 90 contaminants. Every five years, EPA develops a Contaminant Candidate List to consider for regulation and then makes regulatory determinations on some of the contaminants based on scientific information on health effects, occurrence in drinking water and the opportunity for risk reduction.

A health advisory provides technical guidance to federal, state, and other public health officials on health effects, analytical methods and treatment technologies associated with drinking water contamination. Health advisories also contain guidance values that are concentrations of a contaminant in drinking water that are likely to be without adverse health effects.

More information on the perchlorate health advisory:

Researchers focus on bringing bees back

Tuesday, January 13th, 2009

Researchers focus on bringing bees back

The Associated Press

STATE COLLEGE, Pa. - The mysterious decline in honeybees has generated renewed interest into finding new ways to boost bee numbers.

Buoyed by public concern over honeybee hives afflicted with colony collapse disorder, researchers are focusing on how the habitat surrounding a hive can affect the health of the honeybees and native bees like bumblebees.

“The more of these pollinator-friendly areas we have … the more likely we are able to retain bee species,” said Karen Goodell, an ecology professor at Ohio State University whose project focuses on native bees.

Separately, scientists in labs trying to unravel the mystery over colony collapse disorder are focusing on how pesticides and other chemicals used in fields and gardens might affect honeybees, bumblebees and other insects that pollinate crops.

In both cases, researchers want to know how much of what’s outside can affect what’s happening inside the hive.

Bees are vital to American agriculture because they pollinate many flowering crops, including almonds, apples and blueberries.

But honeybees, a non-native species from Europe, are the pollinators of choice in American agriculture because they are easier to manage and are more plentiful , a single colony can contain 20,000 workers. Bumblebee colonies, for instance, may only have a couple of hundred worker bees.

The honeybees have taken a hit over the years by mites and, most recently, colony collapse disorder, in which beekeepers have found affected hives devoid of most bees. Bees that remain appear much weaker than normal.

Beekeepers in 2006 began reporting losing 30 percent to 90 percent of their hives. Since then the annual loss rate has been roughly 33 percent, according to government estimates.

The first case of colony collapse disorder was officially reported in Pennsylvania, and Penn State University has been spearheading research. Maryann Frazier, a senior extension associate at the school’s entomology department, said researchers remain concerned about the number and combination of pesticides that have been detected in decimated hives.

“We realize it’s much more complicated than what we thought a year ago,” Frazier said earlier this month. “From what we know now, it’s not something we’ll figure out very, very quickly.”

Native pollinators are also being monitored. The National Academy of Sciences in 2006 found declining populations of several bee species, along with other native pollinators like butterflies, hummingbirds and bats.

The report suggested that landowners can take small steps to make sure habitats are more “pollinator friendly,” like by growing more native plants.

And that’s what scientists appear to be doing on a larger scale across the country in hopes of bringing bees back.

One such track is at the Environmental Research Institute at Eastern Kentucky University, where apiculturalist Tammy Horn oversees an experiment in apiforestation, a term described by the school as a “new form of reclamation focused on planting pollinator-friendly flowers and trees.”
click here!

The project is in its first year. Horn is working with local coal companies to plant trees, shrubs, and native wildflowers on reclaimed lands that would be attractive to pollinators, rather than the once-typical scenario of planting only high-value hardwoods to establish a timber industry.

There are years of study still to go, though there are no signs of colony collapse disorder so far, Horn said.

Local support from residents and coal companies has been encouraging to Horn. It helps that locals have family ties to beekeeping, with parents and grandparents perhaps dabbling in the hobby before it started to become less popular locally.

The rallying point has been concern about the disappearing bees, she said.

“That’s been important for my project to succeed,” Horn said in a phone interview. “Even people who don’t care about beekeeping show up to (beekeeping workshops) in Eastern Kentucky and know it’s important. They like showing up on mine sites to see that coal mines care enough to invest in it.”

The idea is intriguing enough to draw interest for similar projects in other parts of the country, including California and Pennsylvania.

“It’s a fantastic idea,” said Dennis vanEnglesdorp, acting state apiarist for the Pennsylvania Department of Agriculture. “It’s just a matter of finding time to do everything properly. It’s one of the ways forward for sure.”

At Ohio State, Goodell’s project is housed at The Wilds, a private, nonprofit conservation center located on nearly 10,000 acres of reclaimed mine land in rural southeastern Ohio.

“It’s not as much a scientific study as a ‘Let’s do this and see what happens,’” Goodell said.

Her work deals with native bees, rather than honeybees, though the plight of the honeybees has drawn more attention to all pollinators, she said. The goal is to find the right mix of plants and trees to build native bee populations.

“Those populations would then be contributing to colonizing areas that have lost bees because of poor management,” Goodell said. “Definitely, these bees will be playing a role in pollination services.”

It’s a tact similar to that taken by projects that focus on native pollinators promoted by Mace Vaughan, the pollinator program director at The Xerces Society, a Portland, Ore.-based nonprofit organization.

Its mission, according its Web site, is to “protect wildlife through the conservation of invertebrates and their habitat.”

Vaughan worries that U.S. agriculture might be too dependent on honeybees, though, as with Goodell, programs there have drawn increased interest because of the attention on the honeybee decline.

The ups and downs of energy drinks

Tuesday, January 13th, 2009

AAFES sales are high, but experts debate health effects of popular drinks
By Mark Abramson, Stars and Stripes
Mideast edition, Tuesday, January 13, 2009

Mark Abramson / S&S
Worldwide sales of Red Bull and other energy drinks at Army and Air Force Exchange facilities climbed from about 950,000 units in 2006 to more than 2.47 million in 2008. Dentists and health experts worry about how those drinks can affect people’s health.
Top-selling cold beverages at AAFES for 2008
1. Monster energy drink (16 oz.)
2. Red Bull energy drink (16 oz.)
3. Coke Classic (12 oz.-24 pack)
4. Mountain Dew (20-oz. bottle)
5. Red Bull (8.3 oz.)
6. Mountain Dew Fridge Mate
(12 pack)
7. Monster low carbonated energy drink (16 oz.)
8. Pepsi Fridge Mate (12 pack)
9. Red Bull (12-oz. can)
10. Coke Classic, (20-oz. bottle)

Source: Army and Air Force Exchange Service

Sport drink sales (by container)
2006 - 2,372,620
2007 - 2,330,132
2008 - 2,287,917

Energy drink sales (by container)
2006 - 954,008
2007 - 1,777,057
2008 - 2,475,475
Servicemembers’ thirst for something with a little more oomph than a soda or cup of joe has added some kick to the Army and Air Force Exchange Service’s energy drink sales numbers. But, are those drinks good for you?

According to AAFES, its energy drinks sales worldwide rocketed from 954,008 containers in 2006 to 2,475,475 in 2008. The sales of sport drinks, such as Gatorade and Powerade have declined from 2,372,620 containers to 2,287,917 in the same time span. Energy drinks, such as Red Bull and Monster, now account for five of the top 10 cold beverage sellers at AAFES facilities. Monster energy drinks, 16-ounce sizes, are the No. 1 seller.

“New energy drink flavors seem to evolve and innovate themselves to meet changing demands,” AAFES spokesman Army Lt. Col. David Konop said via e-mail.

Although energy drinks may be healthy for AAFES’ sales figures, guzzling those drinks may not be so good for the consumer, military officials warned.

“I think there are more (health) minuses than pluses,” said Todd Hoover, director of the Army Wellness Center in Heidelberg, Germany, and replication manager for Army wellness centers in Europe. “These are just empty calories because there is no nutrient value in the drinks.”

High caffeine and other ingredients that have the same properties are part of the problem with the drinks, Hoover said.

A 2006 study in the Analytical Journal of Toxicology showed that energy drinks contain up to 141 milligrams of caffeine per serving, compared to 65 to 120 milligrams for coffee and 20 to 40 milligrams for soda.

Hoover said it is unclear what the long-term health effects are of energy drinks because there haven’t been any legitimate studies on the subject. But he said he is concerned about how popular these drinks are becoming — especially downrange.

Energy drink consumption is widespread downrange, where troops are taking coolers full of the drinks with them before they go out on missions and using them to stay awake, Hoover said. He said witnessing that after a recent trip to the Middle East was an eye-opening experience.

But some studies have shown that the drinks are good at improving reaction times, feelings of well-being and energy, Europe Regional Medical Command officials said. Studies have also shown that consuming energy drinks may cause an increased heart rate, nausea, restlessness and tremors.

Dentists worry about the sugar levels.

“Any drink that has a high sugar content, which a lot of these drinks do, could lead to an increase in tooth decay or cavities,” said Air Force Col. Blake Edinger, a doctor of dental surgery at Ramstein Air Base in Germany.

“Every time you take a sip of that drink … the sugar coats the teeth and the bacteria in the mouth attacks that sugar and that forms an acid and that acid will attack the teeth for up to 20 minutes,” Edinger said.

But despite the high sugar and caffeine content, one dental expert said the jury is still out on the effects of energy drinks.

“There are still a lot of studies going on,” said Army Col. Jose Conde, chief of staff for Europe Regional Dental Command. “The energy drinks, some of them don’t have carbonation, but they are very acidic.”

Conde said he is concerned about AAFES’ eye-popping sales figures.

“It could potentially be a big problem, especially if (servicemembers) drink it during deploying status. Their oral hygiene could be a big problem.”

Commodity Forecast World Supply and Demand

Monday, January 12th, 2009

The World Agricultural Supply and Demand Estimates (WASDE) report provides USDA’s comprehensive forecasts of supply and demand for major U.S. and global crops and U.S. livestock. The report gathers information from a number of statistical reports published by USDA and other government agencies, and provides a framework for additional USDA reports.

Latest WASDE Report

The latest WASDE report is available in TXT and PDF.

2009 WASDE Release Dates:

* January 12, February 10, March 11, April 9, May 12, June 10, July 10, August 12, September 11, October 9, November 10, and December 10

Cotton Estimates
NOTE: A special EXCEL table for upland and extra long staple (ELS) cotton estimates will be posted by noon EST on WASDE report release days.

Meat Estimates
NOTE: Meat trade estimates for the May 2008 WASDE are adjusted to reflect revisions by USDA’s Economic Research Service.

Global warming could overheat crops

Monday, January 12th, 2009

SEATTLE, Jan. 9 (UPI) — U.S. researchers say global warming is likely to result in lower crop yields in the tropics and subtropics. leading to serious food shortages.

The food shortages could hurt half of the world’s population, said David Battisti, a University of Washington atmospheric sciences professor.

The report, published in the journal Science, said higher temperatures in the tropics can be expected to cut yields of the primary food crops, maize and rice, by 20 percent to 40 percent. Rising temperatures also are likely to play havoc with soil moisture, cutting yields even further.

“The stresses on global food production from temperature alone are going to be huge, and that doesn’t take into account water supplies stressed by the higher temperatures,” Battisti said Thursday in a release.

Co-author Rosamond Naylor, director of Stanford University’s Program on Food Security and the Environment, warned that it will take decades to develop new food crop varieties that can better withstand a warmer climate.

“We have to be rethinking agriculture systems as a whole, not only thinking about new varieties but also recognizing that many people will just move out of agriculture, and even move from the lands where they live now,” Naylor said.