Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Tuesday, December 7, 2010

Food Safety Regulations


November 30, 2010
Senate Passes Overhaul of Food Safety Regulations
By GARDINER HARRIS and WILLIAM NEUMAN

WASHINGTON — The Senate on Tuesday passed a sweeping overhaul of the nation’s food-safety system, after recalls of tainted eggs, peanut butter and spinach that sickened thousands and led major food makers to join consumer advocates in demanding stronger government oversight.

The legislation, which passed by a vote of 73 to 25, would greatly strengthen the Food and Drug Administration, an agency that in recent decades focused more on policing medical products than ensuring the safety of foods. The bill is intended to get the government to crack down on unsafe foods before they harm people rather than after outbreaks occur.

Despite unusual bipartisan support on Capitol Hill and a strong push from the Obama administration, the bill could still die because there might not be enough time for the usual haggling between the Senate and House of Representatives, which passed its own version last year. Top House Democrats said that they would consider simply passing the Senate version to speed approval.

Both versions of the bill would grant the F.D.A. new powers to recall tainted foods, increase inspections, demand accountability from food companies and oversee farming. But neither version would consolidate overlapping functions at the Department of Agriculture and nearly a dozen other federal agencies that oversee various aspects of food safety, making coordination among the agencies a continuing challenge.

While food-safety advocates and many industry groups preferred the House version because it includes more money for inspections and fewer exceptions from the rules it sets out, most said the Senate bill was far better than nothing.

“This is an historic moment,” said Erik Olson, deputy director of the Pew Health Group, an advocacy group. “For the first time in over 70 years, the Senate has approved an overhaul of F.D.A.’s food safety law that will help ensure that the food we put on our kitchen tables will be safer.”

Among the Senate bill’s last major sticking points was how it would affect small farmers and food producers. Some small-farm and organic food advocates warned that the legislation would destroy their industry under a mountain of paperwork, and Senator Jon Tester, a Democrat of Montana, pushed for a recent addition to the bill that exempts producers with less than $500,000 a year in sales who sell most of their food locally.

That provision led the United Fresh Produce Association, a trade group, to announce recently that it would oppose the legislation since small food operations have been the source of some food recalls in recent years.

But Randy Napier of Medina, Ohio, said the Senate bill was better than nothing. Mr. Napier’s 80-year-old mother, Nellie Napier, died in January 2009 after the nursing home in which she lived continued to feed her contaminated peanut butter even after she got sick.

“I am appalled at what I have found out since my mother’s death about how poorly food is regulated and how these companies cut corners to save money,” Mr. Napier said.

The staunch opposition of Senator Tom Coburn, an Oklahoma Republican, forced months of delay and eventually required Senate Majority Leader Harry Reid of Nevada to call a series of time-consuming procedural votes to end debate. Mr. Coburn offered his own version of the legislation eliminating many of its requirements because he said less regulation was needed, not more, but that version failed.

Despite Mr. Coburn’s opposition, the bill is one of the only major pieces of bipartisan legislation to emerge from this Congress. Some Republican and Democratic Senate staff members — who in previous terms would have seen each other routinely — met for the first time during the food negotiations. The group bonded over snacks: specifically, Starburst candies from a staff member of Senator Mike Enzi, a Wyoming Republican, and jelly beans from a staff member of Senator Richard J. Durbin, an Illinois Democrat. And in the midst of negotiations, the negotiators — nearly all women — took a field trip to a nearby food market so that a Republican staff member could teach the Democrats how to buy high-quality steaks.

“This legislation means that parents who tell their kids to eat their spinach can be assured that it won’t make them sick,” said Senator Tom Harkin, a Democrat from Iowa who, as chairman of the Senate health committee, shepherded the legislation through months of negotiations.

Health advocates are hoping the legislation will rekindle the progress — now stalled — that the nation once enjoyed in reducing the tens of millions of food contamination illnesses that occur each year. In the case of toxic salmonella, infections may be creeping upward.

Part of the problem is the growing industrialization and globalization of the nation’s food supply. Nearly a fifth of the nation’s food supply and as much as three-quarters of its seafood are imported, but the F.D.A. inspects less than one pound in a million of such imported foods. The bill gives the F.D.A. more control over food imports, including increased inspection of foreign processing plants and the ability to set standards for how fruits and vegetables are grown abroad.

And as food suppliers grow in size, problems at one facility can sicken thousands all over the country. The Peanut Corporation of America’s contaminated paste was included in scores of cookies and snacks made by big and small companies. The legislation would raise standards at such plants by demanding that food companies write plans to manufacture foods safely and conduct routine tests to ensure that the plans are adequate.

The bill would give the F.D.A. the power to demand food recalls. The Bush Administration for years opposed such powers, saying that food manufacturers invariably complied when asked by the government to undertake a recall. But last year, the F.D.A. asked a distributor of pistachios to recall its entire 2008 crop after tests showed salmonella contamination at its processing plant. Days passed before the company complied.

The legislation greatly increases the number of inspections the F.D.A. must conduct of food processing plants, with an emphasis on foods that are considered most high risk — although figuring out which ones are riskiest is an uncertain science. Until recently, peanut butter would not have made the list.

Whether the agency gets the money to conduct such inspections is far from certain. The House version would require food producers to pay a modest annual fee to help fund inspections, but that provision was excluded from the Senate version. The Senate bill also requires grocery stores to post prominently a list of recently recalled foods or alert consumers in other ways, a provision championed by Senator Kirsten Gillibrand, a Democrat from New York.

Neither version of the bill applies to slaughterhouses or most meat and poultry processing plants, which are under the jurisdiction of the agriculture department. Both versions would affect about 80 percent of the food supply, including fresh fruits and vegetables, eggs, dairy products and processed foods that do not contain meat.

Industry organizations backed the legislative push because of the high costs for many companies of the food scares of recent years. Egg sales fell nationwide after the massive egg recall this summer, even though only two producers were implicated. Several years ago, contaminated spinach from one small producer led the entire industry’s crop to be destroyed.

Judith McGeary, executive director of the Farm and Ranch Freedom Alliance, an advocacy group that sees government regulation as a threat to small farms, said she was satisfied with changes made to the bill to reduce paperwork for small farmers and exempt them from some requirements.

“We still have concerns about the scope of the power that F.D.A. has and its tendency to write rules and regulations that favor agribusiness instead of small farmers,” Ms. McGeary said.

Scott Faber, a spokesman for the Grocery Manufacturers Association, a trade group that represents most large food processors, said that food sales in the United States and abroad depended on people believing that food is safe.

“Consumer trust is the foundation of everything food companies do, and the industry recognized we needed a stronger partner at F.D.A. if we were going to restore trust in the safety of our food supplies,” Mr. Faber said.

Consumer advocates were jubilant.

“Everyone who eats will benefit,” said Caroline Smith DeWaal, food safety director of the Center for Science in the Public Interest, an advocacy group. “F.D.A. will have new tools to help ensure that we have a safer food supply that causes fewer outbreaks and illnesses.”

***

Now, we all need to work on the Agriculture department to get out meat regulated!
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Tuesday, October 26, 2010

New EPO Like Drug

I think you can tell that I am pretty anti-drug. I just find it hard to believe that people would jeopardize their health for a trophy, or a photo-shoot, a paycheck, it's crazy.

It is one thing if people are stupid enough to mess with their own bodies, but when they bring it into a competition or sporting event, it makes me angry.  What right do they have to cheat and steal from the people who are really working hard to achieve their lifetime dream?

 Runners have been one of the most notorious drug abusers over the years, and I am not just talking about Olympic level runners, but National and even recreational level. Their drug of choice? EPO. Mild mannered little "Susie" probably does all sorts of drugs so she can run so far and so fast, and no one even guesses.

Here is an article I found particularly interesting that just shows how cheaters will continue to do whatever they can to get what they want.

By EDDIE PELLS, AP National Writer Eddie Pells, Ap National Writer Wed Sep 22, 1:22 pm ET
COLORADO SPRINGS, Colo. – A drug that mimics EPO as a way to help patients with kidney problems is in the late stages of development, one in an long list of new pharmaceuticals that anti-doping authorities are monitoring as they struggle to keep sports clean.

The drug, called Hematide, is in Stage 3 development, meaning it could be on the market by 2012. Anti-doping authorities say there's a chance some version of the blood-boosting drug could already be available on the black market.
"It speaks to the length people will go to try to cheat," said Larry Bowers, the lead scientist at the U.S. Anti-Doping Agency. "You get drugs with perfectly beneficial health purposes and it gets diverted for use by people who shouldn't be doing it."

Almost every drug on the World Anti-Doping Agency's banned list, including human growth hormone and steroids, have legitimate medical purposes.
Hematide's arrival is the latest development in a long-running cat-and-mouse game between the drug police and the athletes who find ways to use drugs to improve their performance. Cases involving track athletes Marion Jones, baseball players Barry Bonds and Roger Clemens and an investigation into seven-time Tour de France winner Lance Armstrong have centered around whether they used human growth hormone, EPO or designer steroids, all of which have proven more difficult to detect than traditional steroids.
EPO (short for erythropoietin) is a hormone that boosts the body's production of red blood cells, which carry oxygen — and more oxygen helps athletes perform better, particularly endurance athletes in sports like cross-country skiing and cycling. In 1989, the Food and Drug Administration approved EPO for legitimate medical purposes, mainly to treat anemic conditions in patients with kidney diseases and cancer.

Before Hematide, the most significant development in the line of EPO products was CERA, a version of EPO that stays in the blood for longer periods of time. There was no test available for CERA at the Beijing Olympics, but the International Olympic Committee holds onto doping samples for eight years so it can analyze them later if new testing methods become available.

Using a new test in 2009 is how the IOC retroactively caught five Beijing Olympians for using CERA. This year, the IOC said it was retesting some samples from the 2006 Turin Olympics — strong indicators of how patient anti-doping authorities are willing to be to catch cheaters.

One of the newer drugs on WADA's radar, Hematide essentially does the same thing as EPO — helps produce more red blood cells — but, much like CERA, it stays in the body longer so patients don't have to go through as many treatments.
Still, Hematide is not EPO, and so it must be detected using different methods than were used for the original blood booster. Anti-doping authorities are strategically vague when talking about whether a test is already in place for developing drugs, not wanting drug cheats to know what solutions have been found or perfected. At an anti-doping conference last year, WADA said it was studying a new method that would allow wider testing of EPO.

And in yet another attempt to counter possible new EPO-like substances — as well as all other developing drugs that haven't hit the market yet — WADA recently added a category of "non-approved substances" that covers developing products that are not included in other sections of the list and not yet approved for use.

Hematide, however, is already specifically named on the banned list, said Gary Wadler who leads the WADA committee that determines the banned-substances list.

Earlier this year, WADA signed an agreement with a group representing pharmaceutical companies that gets the companies to voluntarily share information with drug police when they're developing new products. It was considered a breakthrough, giving anti-doping authorities a window into what's out there. In return, WADA has to agree not to share proprietary information between competing companies.

"The mission is to be good citizens here," said Anne-Marie Duliege, chief medical officer at Affymax, the company developing Hematide. "We clear it with the professional agencies who know how to do this. The idea is not to replace WADA. We're just delighted to work with WADA, so they can see what's out there and what they might need to prevent down the road."

It's too early to tell how big a factor Hematide

"We work with the people involved with it. It's not like it came out of nowhere," Wadler said. "We all follow the literature on what's being developed. Something like this does not surprise you at all."
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