FDA Issues Draft Guidance on the Judicious Use of Medically Important Antimicrobials in Food-Producing Animals

FDA Issues Draft Guidance on the Judicious Use of Medically Important Antimicrobials in Food-Producing Animals
The U.S. Food and Drug Administration today issued draft guidance intended to help reduce the development of resistance to medically important antimicrobial drugs used in food-producing animals.
Today’s draft guidance outlines the FDA’s current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture. The FDA acknowledges the efforts to date by various veterinary and animal producer organizations to institute guidelines for the judicious use of antimicrobial drugs, but the agency believes additional steps are needed.
The draft guidance summarizes a number of published reports on antimicrobial resistance and states that the overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production or growth enhancing purposes (i.e., non-therapeutic or subtherapeutic uses) in food-producing animals is not in the interest of protecting and promoting the public health.
The document recommends phasing in measures that would limit medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation. These steps would help reduce overall use of medically important antimicrobial drugs, thereby reducing the pressure that generates antimicrobial resistance.
The FDA recognizes the importance of antimicrobial drugs for addressing the health needs of animals. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years with benefits to both human and animal health. The development of resistance to these drugs, and the resulting loss of their effectiveness, poses a serious public health threat.
“Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine. “FDA is committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a practical strategy to address antimicrobial resistance concerns that is protective of both human and animal health.”
The agency invites comments on the draft guidance, available online and titled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.
For additional information, please see:
Federal Register Notice (this link will expire on Tues., June 29, 2010 and will be updated)
http://www.federalregister.gov/OFRUpload/OFRData/2010-15289_PI.pdf
Draft Guidance for Industry: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf
Q & As: http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm216939.htm

Fw: Press Release: House Agriculture Committee Holds Farm Bill FieldHearing in Fayetteville, North Carolina

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Hearing in Fayetteville, North Carolina

News from the House Agriculture Committee

http://agriculture.house.gov

IMMEDIATE RELEASE
Monday, June 28, 2010

Media Contact:
Liz Friedlander (202) 225-1564
Liz.Friedlander@mail.house.gov
April Slayton (202) 225-6872
April.Slayton@mail.house.gov

House Agriculture Committee Holds Farm Bill Field Hearing in Fayetteville, North Carolina

FAYETTEVILLE, N.C. - Today, the House Agriculture Committee held a field hearing in Fayetteville, North Carolina to review U.S.
agriculture policy, as the Committee begins the process of writing the 2012 Farm Bill. The Agriculture Committee's Chairman of the
Subcommittee on Rural Development, Biotechnology, Specialty Crops, and Foreign Agriculture, Congressman Mike McIntyre (D-N.C.)
chaired the hearing.

This is the ninth in a series of field hearings scheduled across the country to consider new ideas regarding federal food and farm
policy. Four Members of Congress attended today's hearing and heard testimony from eight witnesses on a variety of farm policy
issues.

"North Carolina plays an important role in our nation's agriculture system, and today's hearing was an opportunity for North
Carolina farmers and community leaders to discuss the challenges and opportunities we face," Subcommittee Chairman McIntyre said.
"From commodities to rural development to infrastructure to broadband, we heard a lot of great ideas and suggestions to keep North
Carolina moving forward. As the House Agriculture Committee begins work on the next Farm Bill, these comments will be invaluable as
we work to strengthen our food and fiber production."

According to the U.S. Department of Agriculture, North Carolina is the nation's top producer of tobacco, yielding almost half of the
nation's total tobacco crop. North Carolina also ranks second in the nation among states growing poultry and eggs; hogs and pigs;
and cut Christmas trees and short rotation woody crops. More than 120,000 acres of land in North Carolina are enrolled in USDA
conservation programs.

Approximately 115 members of the community attended the hearing, including local agriculture producers and leaders. Many more
watched the hearing online via a live video feed on the House Agriculture Committee's website. House Agriculture Committee Members
attending the hearing included: Subcommittee Chairman McIntyre; Congressman Larry Kissell of North Carolina; and Congressman Glenn
Thompson of Pennsylvania. Congressman Bob Etheridge of North Carolina, who serves on the House Budget Committee and the House Ways
and Means Committee, also attended the hearing.

"This hearing and others across the nation allow for the sharing of information and best practices from various regions,"
Congressman Glenn Thompson (R-Penn.) said. "Most farms are small businesses and remain the backbone of the strength of the economy
in rural America. Moving toward 2012, the Committee must do everything in its power to alleviate burdens on these family businesses
and create an environment that will foster positive economic growth."

"I am proud to serve as a member of the Agriculture Committee and so pleased to see this hearing taking place in North Carolina.
With North Carolina's agriculture industry responsible for more than $70 billion in economic activity, it is vital that our
agricultural community have input into the upcoming Farm Bill," Congressman Larry Kissell (D-N.C.) said. "North Carolina is one of
the top producing states in tobacco, cotton, soybeans, poultry and hogs, and while we continue to be leaders in these traditional
commodities, our state has quickly become the nation's third most diverse in agriculture."

Written testimony provided by the witnesses is available on the Committee website: http://agriculture.house.gov/hearings/index.html.
A full transcript of the hearing will be posted on the Committee website at a later date. To receive updated schedule and news
information from the House Agriculture, please visit the House Committee on Agriculture website to sign up for email updates:
http://agriculture.house.gov/Eupdates/updates.html.

Witness List

Panel I
. Mr. Ronald Allen, row crop, timber, pork, poultry, and beef producer, Fayetteville, North Carolina
. Mr. Steven Burke, biofuels representative, Oxford, North Carolina
. Mr. Frank Lee, corn, cotton, wheat, soybean, and beef cattle producer, Raleigh, North Carolina
. Mr. Allen McLaurin, cotton producer, Laurinburg, North Carolina

Panel II
. Mr. Patrick Woodie, on behalf of Mr. Billy Ray Hall, rural economic development representative, Raleigh, North Carolina
. Mr. Randall Jones, electric cooperative representative, Red Springs, North Carolina
. Mr. Tommy Porter, pork, beef, and poultry producer, Concord, North Carolina
. Mr. Dan Ward, peanut producer, Clarkton, North Carolina

###

The U.S. House Committee on Agriculture web site http://agriculture.house.gov has additional information on this and other subjects.

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The Onion's Best Friend Is an Ogre

http://online.wsj.com/article/SB10001424052748704123604575323433042544568.html?ru=yahoo&mod=yahoo_hs#articleTabs=article


The Onion's Best Friend Is an Ogre


VIDALIA, Ga.—On a recent visit to a Thriftway supermarket near this onion-growing center, Aiden Harvill spotted a jolly green giant at a bin stuffed with Vidalia onions. "Mama, there's Shrek," the three-year-old shouted. He then threw a tantrum until his mother plopped a bag with Shrek's image into her shopping cart.

"He never, ever eats vegetables, but when we got home, he wanted me to cook them," Elizabeth Harvill says. She diced the onions into a casserole, which Aiden gulped down. "I was astonished," Mrs. Harvill says. "It was like a toy in a cereal box."

"Shrek Forever After," the fourth Shrek movie, had a slow start at the box office before picking up steam. But in the produce section it is creating a minor sensation, by making onions popular with kids.
[Onion] Brent Magee

'Shrek' has been the perfect pitchman for Vidalia onions.

The movie, which has since gone on to do big business, has spawned tie-ins with companies ranging from Hewlett-Packard Co. to Bank of America. But none is as bold as the one advanced by the Vidalia Onion Committee, an association that represents 100 growers of the Vidalia, a trademarked sweet onion that is unique to southeastern Georgia.

The campaign, "Shrek Forever After, Vidalias Forever Sweet," was unveiled this spring in conjunction with the release of the flick and the start of the Vidalia season, which stretches to September. The onion association's partnership with DreamWorks Animation SKG Inc. uses the movie's characters on packaging, store displays and on a website.

Through June 14, the U.S. Department of Agriculture said, farmers had shipped eight million more pounds of Vidalias than by the same date last year—though the 2010 season started two weeks later than in 2009. "We've sold more onions up to this point in the season than we ever have in the past," says Brian Stanley of Stanley Farms, a large Vidalia grower.

The third-generation onion farmer recently had to get his produce-bag supplier to fly in an emergency order of "Shrek" packaging. His onions are packed in mesh bags coated with color photos of the ogre Shrek, the Vidalia onions logo and the question: "What do Ogres and Onions have in common?"

The Vidalia Onion Committee has promoted with A&W root beer, to appeal to families and with Corona beer, to appeal to young adults. "My problem was how to market onions to kids. It's a lot easier when you're talking apples, strawberries and bananas," says Wendy Brannen, executive director of the Vidalia Onion Committee.

In Atlanta, Steve Langston, a food marketer who had been courting the committee, was brainstorming last summer in his office with two college students. One remembered a scene in the first Shrek movie, in which the ogre tells Donkey that "there's a lot more to ogres than people think...." Ogres are like onions, Shrek says. It's not that both might be stinky, make you cry or get all brown in the sun. Rather, it's that "we both have layers," he explains.

Mr. Langston, who has arranged tie-ins with Hollywood studios before, took the idea to Ms. Brannen, who got the go-ahead from the farmers. He took the idea to DreamWorks. "There was a natural connection between their brand and our character, since onions were rooted in Shrek's personality from the first movie," says Anne Globe, head of world-wide marketing at DreamWorks Animation. A tie-in with McDonald's Corp. backfired, after the fast-food chain had to recall glasses tainted with cadmium, a toxic metal.

DreamWorks and the grower association spent a year hammering out details of the ogre-onion campaign. The Georgia farmers covered the costs of marketing, including making the stands and promotional items. But the studio had vetting power every step of the way.

When Vidalia hired a chef to develop recipes for the campaign, DreamWorks scrutinized them and perfected their names. The results: Swampy Joes, Shrek-O-licious Summertime Succotash and Donkey's Savory Onion Parfait.

There's no telling whether the campaign will have a lasting effect on children's newfound love for onions.

And Vidalia had more going for it this season than an animated ogre. Bad weather undermined onion output in Texas and California, benefiting Vidalia. But Vidalia itself was hit this year by excessive rain and a cold spell, which delayed the harvest by two weeks.

Still, "there's no question that Shrek has driven sales at the consumer level," says John Tumino, a sales director at Richter & Co., a Charlotte, N.C., company that supplies onions to Safeway, Hannaford and other chains. "Children are enamored of Shrek." He estimates that demand for medium-size Vidalias, which typically fill Shrek bags, is up 30% to 35% this year.
[ONION]

Elias Freij, produce manager at a Food World supermarket in Mobile, Ala., says his store has been selling nine or ten 40-lb. cases of Vidalias each week, nearly three times last year's weekly volume.

"Don't get me wrong, Vidalias always sell," says Mr. Freij, who was recently selling four-pound Shrek onion bags for $3.49 and loose Vidalias for $1.29 a pound. "But when you promote it with kids, it's an automatic sell."

To whet kids' appetite, a Hy-Vee Food Stores Inc. supermarket in Atlantic, Iowa, broadcast the question, "What do onions and ogres have in common?" It tells shoppers: "Go to vidaliaonion.org to find out."

Produce manager Brent Magee says that many kids have returned to the store days later to inform him, "Hey, they both have layers."'

The supermarket erected a 16-foot onion display with cardboard cutouts of Shrek and Donkey. In the first week the display was up, sales tripled, says Mr. Magee. Since then, onion sales have slowed, but he says he is continuing to sell double the amount of onions he did before the promotion.

Tamara Gibson, a 40-year-old personal trainer and mother of three, says her four-year-old, Grayson, could hardly contain his excitement at the sight of Shrek at the Hy-Vee. Normally, "he only gets that giddy when we're in the packaged-food aisle with really sugary things."

She had made multiple trips to Hy-Vee to stock up. "I was at the store last night and thought, 'gosh, I'm going through onions like crazy these days.' It's like buying milk!"

Write to Miriam Jordan at miriam.jordan@wsj.com and Lauren A. E. Schuker at lauren.schuker@wsj.com

Do the benefits of organic farming outweigh the higher costs?

http://www.journalgazette.net/apps/pbcs.dll/article?AID=/20100627/EDIT10/306279943/1021/EDIT

Do the benefits of organic farming outweigh the higher costs?
Stacey Stumpf | Editorial Writer for The Journal Gazette
Swiker Patel | The Journal Gazette
Angela Stiverson holds Jonah Brindle, 8 months, as he reaches for chocolate chip bread at the Salomon Farm market.

Just five years ago there was one farmers market in Fort Wayne – the historic South Side Farmers Market on Warsaw Street. The opening of the East State Village Farmers Market today brings the count of farmers markets to at least six within the city limits and several more in nearby communities.

The increasing popularity of farmers markets is one indicator of the increasing interest residents have in buying more locally grown fruits and vegetables – organically grown crops are especially attractive.

"People are really interested in shopping at farmers markets. It's a lot less expensive … and you can have more confidence with what you are buying," said JoAnn Wall-Beer, a member of the East State Village Association and organizer of its market.

The East State Village Farmers Market is open from noon to 4 p.m. on Sundays at the plaza at the Tecumseh branch of the Allen County Public Library, 1411 E. State Blvd. Wall-Beer said the group specifically chose Sundays because it would not compete with other farmers markets and because it would give people something fun and interesting to do with their families after church.

Organic obsession

Increasing interest in buying organic fruits and vegetables is also playing out on the retail side at supermarkets.

"Customers are becoming, and have been for over 10 years, more interested in organic produce for all the right reasons," said Gregg Proctor, produce merchandiser for Kroger. "We continue to see growth in that area and have seen double-digit growth for over 15 years." In the last five years, sales of organic produce have increased 20 percent. And he said that in spite of the bad economy, Kroger has not seen any dip in organic food sales.

Proctor said Kroger has increased the variety of organic options available in stores, as well as the display space, advertising and signage devoted to organic produce, dairy, frozen and packaged foods. He notes some organic items, such as lettuce, are not always available throughout the year.

According to the Organic Trade Association's 2010 Organic Industry Survey, U.S. sales of organic food and beverages grew from $1 billion in 1990 to $24.8 billion in 2009. The sale of organic fruits and vegetables had the highest growth with an increase in 2009 of 11.4 percent over 2008 sales.

The growing conviction is organic fruits and vegetables are more nutritious and better for the environment. It doesn't matter how it's grown, a carrot is always going to be a much better snack than a Twinkie. But one theory is that organic plants – much like the human body – rely on antioxidants as part of a defense system, and the lack of chemical assistance in that process leads to a greater buildup of antioxidants.

A celebrated study from the University of California in Davis found organic tomatoes have almost double the concentrations of two flavonoids – healthy plant nutrients – than conventionally grown tomatoes. The 10-year study found organic tomatoes had 79 percent higher levels of the flavonoid quercetin and 97 percent higher levels of the flavonoid kaempferol. These nutrients are said to play a role in heart health.

The researchers were adamant that while the research strongly suggested organic is better, many factors – soil quality, water and seed variety – could affect the plants. The research is part of a long-term study that began in 1991 and is expected to continue for 100 years. More research is needed before scientists can conclusively rule that organic vegetables are substantially more nutritious than conventionally grown crops.

The case in favor of going organic is more evident when considering the benefits to the environment. The damage to soil and water quality from pollution caused by chemical pesticides and herbicides is obvious. Overuse of chemical fertilizers also causes environmental damage, including water contamination and algae blooms that kill aquatic life.

Certified organic

Frank Guglielmi, Meijer spokesman, said organic food has become so popular the store launched its own line of organics.

"The key is that it's USDA certified organic, that is the important distinction," Guglielmi said.

The buzzwords can become confusing. "Natural" is not the same as "organic," and not all veggies labeled organic are equal. The gold standard is certification from an organization with accreditation from the U.S. Department of Agriculture's National Organic Program.

Joseph Graber, whose more than 100-acre Harlan farm sits near the Ohio border, gets his organic certification from the Ohio Ecological Food and Farm Association. The Amish farmer pays an annual $650 fee, keeps detailed documentation about his farming practices and allows inspectors access to his property to qualify for certification. The process to be certified takes three years, and Graber has had his certification for the last four years.

Instead of applying herbicides to the 10 to 20 acres he is farming at any given time, he and his farmhands have to pull the weeds by hand. He also uses floating row covers – loosely woven fabric to covers the crop rows – and black plastic with holes cut for the plants to prevent weed growth.

Instead of spraying pesticides to keep bugs away, he has to use natural repellents, including sugar water or a chamomile mixture, to keep his plants healthy. And he uses natural fertilizer (manure) instead of chemicals to encourage his crops to grow.

"I know it's a lot more work, but I'd rather, I guess, build the soil rather than destroy the soil," Graber said. "I know that I'm selling something that's going to make someone healthier rather than make them sick."

Graber supplies produce to several local restaurants, the Three Rivers Food Co-op on Sherman Boulevard and the Health Food Shoppe on North Anthony (as well as my family – see the chart on Page 13A). He also sells his produce at local farmers markets, specifically the Salomon Farm Market on Dupont Road (open on Wednesdays) because it focuses on locally and organically grown items.

He said that there is more work for a smaller yield, but having an organic farm "gives you a chance to still have a family farm."

Cost concern

The major drawback to buying organic food is higher costs. Organic fruits and vegetables cost more because it takes more time and labor to grow organic crops.

Proctor said the cost of organics can also fluctuate wildly depending on supply. "It can easily be two or three times more expensive, and we can't retail at that level. With organics we have to be very careful so we don't price people out of the market. Organics are always more expensive, but sometimes it's nominal."

John Elliot, spokesman for Kroger, said, "Customers have the ability to affect price. If customer demand increases sales, the price goes down for us, and we share that with customers." And he said Kroger deliberately will "give up some of our margin to try to induce our customers" to buy organic.