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Archive for the 'Law & Regulations' Category

No quick fix to the food price crisis

From FoodNavigatorUSA 

 The food crisis is neither new nor sudden. The several underlying causes have been independently, steadily gathering speed and have collided in a perfect storm not seen for generations. It is going to take a coordinated, long-term effort to untangle them.

At FoodNavigator.com we have been reporting on rising costs since 2003. Reducing costs and protecting margins has been a long-term battle for manufacturers.But in recent weeks the situation has reached new shades of gloom, as governments around the world have taken steps to reduce the impact on their populations (and protect their own positions of power).No-one wants to be the next Jacques-Edouard Alexis, the Haitian prime minister dismissed by the senate after wide-spread rioting over food prices.

Even so, the life sentence in prison faced by anyone found to be hoarding rice in the Philippines is extreme, at least by Western judicial systems.

And yet, the World Food Programme’s stark warning that the world’s poorest folk are facing starvation rather puts our grumbling about the upward creep of grocery bills in context. 

Various solutions have been bandied about in the last week. In fact, finding the solution has become a battleground of ideologies.

US and European policy to increase use of biofuels - once seen as the great hope for reducing reliance on fossil fuels and environmental protection - could now be on course for a U-turn.

It is generally agreed that biofuels’ demand on corn and other grain supplies is not the main or only cause of the current situation. Experts have estimated that their contribution to the current scenario is between 10 and 30 per cent.

The EU’s target that 10 per cent of energy should come from biofuels by 2020 may well need to be put on ice, at least until second generation biofuels based on cellulose from waste materials are developed to an industrial level.

Elsewhere, an editorial in The Lancet criticised rich countries for “dumping subsidised produce into the markets of poor nations, wrecking the livelihoods of local farmers in those countries.”

French agriculture minister Michel Barnier, meanwhile, said in an interview with The Financial Times that he would not allow European subsidies and trade barrier system to be blamed for high commodity prices.

Rather, he recommends that Africa and Latin America adopt their own versions of the European Common Agricultural Policy - and he believes the EU should be providing money and know-how to help them develop parallel policies.

The Economist said that, as a first step, rich countries should be bridging the $700m gap in the World Food Programme’s funding this year that has emerged as a result of higher prices for the rice and other basics it distributes to famine-struck regions.

$700m is not a lot in the grand scheme of things. It’s about one 148th of the annual turnover of Nestle, the world’s largest food company.

The newspaper admitted that such funding would be a palliative and that a longer-term approach to stopping trade distortions. But The Lancet has said that hand-outs, however well-meaning, are ineffectual if the countries making them do not “stand up to their own farmers” and abolish subsidies.

Such debate, whether conduced through the media or at a world summit as proposed by UN secretary general Ban Ki-moon, is crucial.

But the problem is only going to be solved if political consensus can be reached and a multi-lateral, international strategy is put in place - and fast.

For almost a decade we (in the West, at least) have been growing fat and arrogant on low-cost food, believing that, at last, we have got food supply licked.

It’s time to put arrogance aside and take the first steps down what looks to be a long road to a brand new model for global food supply.

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New BPA evidence piles pressure on FDA to set exposure limits

Note: The dangers and concerns about bisphenol A are described in my book, Raise a Smarter Child by Kindergarten.

David Perlmutter, MD, FACN

FromFoodNavigator.com

Pressure is growing on the US Food and Drug Administration to set new restrictions on the use of the chemical bisphenol A (BPA) in food packaging following a new safety study. A report from the US National Toxicology Program (NTP) concluded that there was “some concern for neural and behavioural effects in foetuses, infants, and children at current human exposures” to BPA, which is used extensively in the plastic lining in food cans.

A report from the US National Toxicology Program (NTP) concluded that there was
to BPA, which is used extensively in the plastic lining in food cans.According to the NTP, there was evidence that BPA could induce cancer in humans at current exposure levels, although it stressed that “more research is needed”.

The report, published earlier this week, has already prompted calls from senior US politicians for rapid action from the FDA, which has previously cleared BPA for use in food packaging.

Existing concerns

This is not the first study to suggest a link between cancer and BPA. A report published last year by Environmental Working Group (EWG), a non-profit environmental research organisation, showed that the chemical could leach into canned food at levels reaching 200 times the ‘acceptable’ amount.

As yet, the FDA has set no maximum exposure levels for BPA - EWG’s ‘acceptable’ level was based on government studies on rodents, with human exposure typically set to between 1000 to 3000 times the levels that harm lab animals.

But it is the NTP’s suggestion that BPA could be harmful even at ‘normal’ exposure levels that has prompted calls for the FDA to finally set some form of maximum intake level, in line with regulators elsewhere.

The European Food Safety Agency last year set a tolerable daily intake (TDI) level for BPA of five milligrams/kg body weight/day - but stressed that current exposure levels were just 30 per cent of the TDI.

Industry

Can makers insist that there is insufficient evidence to show that the chemical is a health risk given the current exposure levels.

Robert R. Budway, president of the US Can Manufacturers Institute, whose members account for around 80 per cent of all the cans produced there, told FoodProductionDaily.com last year that the levels of BPA in food found during the EWG study were well below the TDI level set in Europe.

“In fact, the single highest value they reported is approximately 10 times lower than the EU allows,” he said at the time.

But in many ways the harm has already been done: “Reduce your use of canned foods,” the NTP recommends to consumers wanting to avoid BPA, adding “when possible, opt for glass, porcelain or stainless steel containers, particularly for hot food or liquids” - a recommendation that could prove highly damaging for the US can manufacturing sector if producers also start to seek alternative packaging sources.

Budway said that despite the lack of concrete evidence surrounding a BPA health risk, it was likely that can makers were looking for alternative solutions, although he was “not aware of any specific cases” at the time.

Meanwhile, health officials in Canada are reported to be considering banning all use of BPA in food packaging - a decision could be made as early as this week, according to press reports - making it the first country to declare the chemical unsafe.

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Bill to Regulate Tobacco Moves Forward

From New York Times

The House Commerce Committee approved a bill Wednesday that would give the Food and Drug Administration sweeping regulatory authority over the tobacco industry, clearing the way for a floor vote on the legislation, which has long been sought by antitobacco activists.

The bill is meant to severely curtail tobacco marketing, to emphasize health warnings on tobacco products, to ban many flavored cigarettes, and to prohibit labeling of cigarettes as light or low tar. Dozens of health groups have supported the bill as potentially life-saving.

But despite broad support in both the House and the Senate, where a similar proposal cleared a committee in July, the legislation faces formidable obstacles.

The Bush administration and the Senate Republican leader, Mitch McConnell of Kentucky, have indicated their opposition.

In a statement shortly after the vote, a White House spokeswoman, Emily A. Lawrimore, said the administration thought that the legislation would do more harm than good, creating a false impression that regulated tobacco products were safe.

The administration believes that tobacco is not a drug or device to be regulated by the F.D.A., Ms. Lawrimore said.

A spokesman for Senator McConnell noted that he had said he would review the bill.

Senator Richard Burr, Republican of North Carolina, has reportedly threatened to filibuster the legislation if it reaches a vote on the Senate floor. In a statement Wednesday, shortly after the House committee vote, Mr. Burr said he remained opposed to the legislation, in part, he said, because it would strain an already burdened agency. The bill is also running up against an abbreviated election-year legislative schedule.

The House committee approved the bill 38 to 12, with much of the opposition from Republicans who argued that the F.D.A. was already overwhelmed and could not handle regulating another industry.

That position has recently been articulated in an advertising campaign by Reynolds American, the tobacco company that sells Camel cigarettes and other brands. But Representative Henry A. Waxman, Democrat of California, who sponsored the bill, said such arguments were clearly red herrings from those who are fundamentally opposed to regulating tobacco at all.

And Representative John D. Dingell, Democrat of Michigan and the Commerce Committee chairman, said he was separately working on legislation to clean up this mess at Food and Drug, and we plan to do it with all vigor and enthusiasm.

The tobacco bill has been endorsed by the cigarette maker Philip Morris, and some people have criticized it as a compromise that does not go far enough. For example, it prohibits the F.D.A. from raising the legal age for buying cigarettes beyond the current level of 18.

And while the bill prohibits the sale of candy-flavored cigarettes

which account for less than 1 percent of the market

it allows the continued sale of popular menthol cigarettes. One menthol brand, Newport, marketed by Lorillard Tobacco, is the nations second-leading cigarette, after the Philip Morris brand Marlboro. Lorillard has not yet taken a position on the legislation, a spokesman said.

Representative Mike Ferguson, Republican of New Jersey, offered an amendment that would have prohibited menthol flavoring. I think its inconsistent to say we want to protect kids from flavored cigarettes,

Mr. Ferguson said, but then we have a provision in the bill that allows menthol cigarettes.

Mr. Dingell acknowledged that the legislation was not ideal. In a perfect world, wed ban all cigarettes, he said. But the hard fact of the matter is that there are a lot of jobs depending on this. And more importantly, there are a lot of people out there who are addicted to this, and theyve got to have their fix.

Antismoking groups have sought regulation of the tobacco industry for years. In 1995, a former F.D.A. commissioner, David A. Kessler, drafted regulations declaring nicotine a drug and cigarettes a drug delivery device subject to F.D.A. authority, but these were struck down by federal courts.

The Senate approved a proposal in 2004, but the House has never voted on one.

Within minutes of Wednesdays action, statements supporting the committees vote were issued by supporters including Senator Edward M. Kennedy, Democrat of Massachusetts, who sponsored the Senate version of the bill; the American Academy of Pediatrics; and the American Cancer Society.

Although the White House had expressed its opposition, it has not yet threatened to veto the legislation. In testimony last fall, Dr. Andrew C. von Eschenbach, the current F.D.A. commissioner, indicated the Bush administrations reluctance to embrace a new regulatory role, citing wide efforts already begun by both state and federal agencies to reduce tobacco use.

The bill would create a center within the F.D.A specifically for tobacco regulation financed by industry fees projected to exceed $5 billion over the next 10 years.

It would also require disclosure of the contents of tobacco-based products and set standards that would require removal or reduction of harmful ingredients; require that the findings of industry research be made public; prohibit companies from making health claims about tobacco products, and require larger and more effective warning labels.

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States alter rules of game on safety for toy makers

From WSBT.com

In a move that has alarmed the toy industry, lawmakers in the state of Washington have overwhelmingly passed a bill that would set the toughest restrictions in the nation on the lead content of children’s products.

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Recalls

The bill would reduce the allowable level of lead in toys and other goods to 90 parts per million

and possibly as low as 40 parts per million, the recommended limit of the American Academy of Pediatrics, and far below the current federal standard of 600 parts per million. It would also set tough limits on cadmium, a metal used in paints and plastics, and on plastic-softening chemicals called phthalates that have been linked to childhood developmental problems, in some studies.

Some small toy makers say they are planning to stop selling in the state if, as they expect, Democratic Gov. Chris Gregoire signs the bill in coming days. The cost of certifying their products as safe under the law, they say, would be prohibitive. The state accounts for about 2 percent of total U.S. toy sales, which last year equaled $23.5 billion in annual revenues.

In a last-ditch effort to stop the measure, representatives of Mattel Inc. and Hasbro Inc., the country’s two biggest toy makers, met with Gov. Gregoire March 17, according to people familiar with the matter. At that meeting, and elsewhere, these people say, Mattel has told Washington officials that half of the products made by its Fisher-Price unit, which specializes in products for preschoolers, would be barred from the state if the law is adopted. The new restrictions would take effect in July 2009.

Mattel didn’t return several calls and emails seeking comment. Hasbro confirmed a meeting with the governor and declined further comment.

The Toy Industry Association, or TIA, which represents more than 75 companies, has said it wouldn’t make economical sense for toy makers, large and small, to ship products to the state if the bill becomes law.

Washington is just one front in a toy-safety battle that has erupted at the statehouse level since Mattel and others withdrew millions of toys to protect children from lead paint and choking hazards this past summer.

The dangers, which can occur when children put toys in their mouths, were generally attributed to Chinese manufacturers hired by the U.S. companies. Last week, the Reebok unit of Adidas AG paid a $1 million penalty as part of a settlement with the U.S. Consumer Product Safety Commission for distributing a lead-tainted charm bracelet that was swallowed by a four-year-old boy, who died of lead poisoning.

Congress is considering new federal lead limits and other toy-safety standards but isn’t moving fast enough for sponsors of bills in 29 state legislatures. Illinois and Michigan have already enacted new lead laws, which aren’t as tough as the Washington bill. A ban on phthalates is due to take effect in California next year. The TIA says it has hired lobbyists to battle legislative proposals in 10 states, including Connecticut, Maine, Maryland, Massachusetts, Minnesota, Vermont and Wisconsin.

Many state lawmakers are upset that Congress and federal regulators haven’t done more since the recalls. “If the federal government would do something I would gladly defer to them, but they aren’t, so we have to,” says Illinois Rep. Elaine Nekritz, author of one of two bills that would go beyond the one the state already enacted.

Of the laws under consideration at the state level, 24 regulate lead, 18 cover phthalates, 10 set limits on mercury, and 17 address a variety of other potential toxins. With more state laws possible, makers of toys and other children’s products are afraid that regulatory compliance will turn into a manufacturing nightmare.

“Having different standards for different states is just going to create complete chaos,” says Carter Keithley, the TIA’s president.

Toy makers have generally been reluctant to say how many of their products would fail to meet the Washington bill’s standards. According to lab tests last fall sponsored by more than two dozen consumer groups, 24.8 percent of the 1,200 randomly selected toys sold in the U.S. contained lead in quantities that would exceed the limit in the Washington bill, and 2.9 percent had cadmium above the limits.

Last month, the Washington Toxics Coalition, an environmental advocacy group in Seattle, said it commissioned a test of 20 toys for phthalates and found that nine contained levels exceeding the 1,000 parts per million limit proposed by Washington

the same limit that has been in effect in the European Union since 2005.

A spokeswoman for Target Corp., which had two store-branded toys on the list, says the company intends to abide by the law if it is enacted. She noted that there aren’t any current restrictions against phthalates in the U.S. and added that the retailer plans to phase them out by the fall of this year in its store-branded toys.

Toys “R” Us Inc., the No. 2 toy retailer by revenue, said it is too early to say how the Washington measure would affect its business in the state, Wal-Mart Stores Inc., the biggest retailer of toys, didn’t respond to questions.

The state would, among other things, compile a list of “high-priority” chemicals and require companies to file statements annually disclosing the levels of these chemicals in any of their products. That would mean paying for testing that some toy vendors estimate would cost $500 per product, toy makers say.

Mark Chernick, chief executive of Seattle-based Play Visions Inc., a closely held company that makes bathtub toys, puppets and balls, says that would add 5 percent to 10 percent to his overhead

enough to keep him from selling in the state. “That’s basically my profit,” he says. “It’s not worth it.”

Rex Tompkins, a U.S. representative for German toy maker Kaethe Kruse Puppen GmbH says the maker of infant toys, rattles, teeters and dolls, won’t ship products to Washington, either, if the bill becomes law. Neither will Toysmith, an Auburn, Wash., wholesaler and maker of dice, tops, play microscopes and other toys, according to Bill Smith, the company’s chief executive. The company also sells to retailers elsewhere in the U.S., Europe and Japan.

Toy makers also complain about what they see as favored treatment for videogame makers, who received an exemption from the bill. Nintendo Ltd., maker of the Wii videogame, and Microsoft Corp., which makes the Xbox, are both based in Redmond, Wash. Lead is commonly present in electronic-circuit soldering.

“There is an illogic in the legislature’s reasoning,” argues Rick Locker, a lawyer for the TIA, “toys with electronics are dangerous but videogames with the same type of electronics aren’t.”

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Will Wyeth Bully You Out of Your Estriol?

From NaturalNews.com

The FDA has begun 2008 by forbidding compounding pharmacists to use estriol in their natural hormone formulations because the agency doesn’t have a specified approved use for it. They took this action because Wyeth complained about it. And yet, Wyeth-Pharma sells two types of estriol drugs in Europe, so we know this is not a safety and efficacy issue.

In case you’ve forgotten, Wyeth is the giant pharmaceutical company that makes Premarin and PremPro, synthetic hormones found to cause heart disease, strokes and cancer. If we do some rough calculations based on statistics from the Women’s Health Initiative (WHI), Wyeth’s hormone replacement drugs have killed tens of thousands of women over the past few decades. Sales of these dangerous drugs have plummeted since the WHI results were announced, and women who were injured by them and sued, are winning millions in damages in courtrooms around the U.S. (You go girls!) .

Estriol is a Safe Alternative

Estriol, on the other hand, is a mild (natural) estrogen that’s primarily used in cream form for vaginal dryness and urinary tract problems in menopausal women. It’s been in common use in Europe for 30 years, and its safety and effectiveness are well established. Many doctors in the U.S. who use natural hormones prescribe tri-est and bi-est, estrogen cream formulations made by compounding pharmacies that contain estriol. These formulations appear to be what Wyeth perceives as its competition. If you’d like to know more about estriol, Dr. David Zava wrote an entire chapter about it in What Your Doctor May Not Tell You about Breast Cancer ((http://www.virginiahopkinstestkits.com/…) .

Here’s what the medical literature states about Ovestin, an estriol cream made in Europe: “Ovestin contains the natural hormone estriol, which is a weak estrogen. It treats urogenital symptoms without causing adverse changes to the endometrium, which means that it can be used without a progestogen in women with an intact uterus… The absence of progestogen-induced withdrawal bleeds with Ovestin makes it highly acceptable to women.”

The doctors and pharmacists can take the estriol out of the formulas and they’ll still work well because they also contain estradiol, but ironically they probably won’t be quite as safe. Estriol may have some protective properties that balance estradiol’s cancer-promoting effects. In fact, estriol is so safe that it’s the primary estrogen of pregnancy - the fetus is bathed in it.

The Bully in the Neighborhood

It’s shameful of Wyeth to use its clout and money to bully and beat on the competition through the FDA, but by now we expect that behavior from them. The real shame is that the FDA can’t seem to stop itself from being bullied. You can bet there was some major arm twisting going on to push the FDA into this action, because they just have to know that it’s been proven safe and effective in Europe, and that thousands of annoyed menopausal women are going to be sending them e-mails. We can only hope that the FDA responds by quickly reviewing the body of excellent research available on estriol and taking action to assign it some specific and approved uses.

In the meantime, if big bad Wyeth succeeds in taking your estriol away, and you can’t have sex because of vaginal dryness, send your partner to Washington to march on the FDA’s doorstep. Just kidding.

This is an especially poignant issue for women with breast cancer or who have had breast cancer, because estriol is a safe alternative to estradiol. The estrogen-blocking drugs such as tamoxifen that are used to treat breast cancer can cause terrible vaginal dryness and urinary tract problems, and even without the drugs, these are serious problems for many menopausal women.

Estradiol cream is an effective, albeit less safe, treatment for vaginal dryness and urinary tract problems. Please use the lowest dose possible that relieves symptoms and use progesterone cream for balance. For details, I recommend that you read Dr. John Lee’s Hormone Balance Made Simple

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