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Friday, February 29, 2008

EPA's Topsy-Turvy Definition of Conflict-of-Interest

Here's a gem from today's Los Angeles Times:

Under pressure from the chemical industry, the Environmental Protection Agency has dismissed an outspoken scientist who chaired a federal panel responsible for helping the agency determine the dangers of a flame retardant widely used in electronic equipment.

Toxicologist Deborah Rice was appointed chair of an EPA scientific panel reviewing the chemical a year ago. Federal records show she was removed from the panel in August after the American Chemistry Council, the lobbying group for chemical manufacturers, complained to a top-ranking EPA official that she was biased.

Rice has outspokenly advocated for a ban on the flame retardant, deca, because she believes existing science proves the substance is harmful even at low levels. According to the LA Times, Rice is "an award-winning former EPA scientist who now works at the Maine Department of Health and Human Services."

So what is EPA's justification for her dismissal? "EPA officials removed Rice because of what they called 'the perception of a potential conflict of interest.' " What is the conflict here? The fact that she is a human?

Not only did EPA remove Rice from the panel, they also deleted her portions of an upcoming report regarding the chemical's safety. That could have major regulatory implications, as Andrew Schneider of The Seattle Post-Intelligencer reports:

EWG and two scientists in EPA with whom I spoke this morning, said the omission of Rice's comments from the review document could result in a significantly weaker safety standard for the chemical, which EPA intends to propose at the end of March 2008.

A proposed rule published in March gives EPA just enough time to gather comments and finalize the rule before the clock runs out on the Bush administration.



Posted by Matt Madia, 05:33:20 PM



Thursday, February 28, 2008

Regulatory Hit-List Finalized

Today, the Small Business Administration Office of Advocacy announced its final list of regulations under its regulatory review and reform initiative. Ultimately, this list tees up 10 rules the Bush administration may attempt to rollback in its final year in office.

Last year, the Office of Advocacy solicited nominations for rules it could then push federal agencies to modify. Business owners, industry lobbyists, and anti-regulatory think tanks nominated more than 80 such rules.

The final list shows a bias against public health and safety standards. Four of the rules the Office of Advocacy will target are EPA rules: dry cleaner air monitoring; drinking water systems; solid waste recycling; and oil spill prevention.

Two other rules are occupational health standards. One is an OSHA rule protecting lab and medical workers from exposure to bloodborne pathogens. Another is Mine Safety and Health Administration (MSHA) rule regulating the use of explosives in mines.

Another rule places restriction on flights around the Washington D.C. metropolitan area. The Federal Aviation Administration (FAA) issued the rule as an interim rule in the wake of the September 11 attacks and plans to finalize it, according to the Office of Advocacy.

Of the remaining three rules, one is an IRS rule regarding home office deductions, and the other two relate to federal procurement and contracting.



Posted by Matt Madia, 03:50:56 PM



Tuesday, February 26, 2008

Toys "R" Us Announces Lead, Phthalate Standards

Toys "R" Us has announced plans to enforce a voluntary standard for lead in toys tighter than the mandatory federal standard. According to the retailer's press release, "We have instructed all manufacturers who produce items for Toys "R" Us, Inc. that products shipped to the company on or after March 1, 2008 must comply with strict new standards, which include…applying a more stringent standard of 90 ppm for lead in surface coatings versus the current federal standard of 600 ppm for all products manufactured exclusively for Toys "R" Us, Inc."

While reducing lead in toys is a no-brainer, Toys "R" Us should receive extra commendation for also moving to ban phthalates in toys. As BNA news service reported this morning, Toys "R" Us plans to require all products sold in their stores to be phthalate-free by the end of 2008.

Studies have shown phthalate exposure to cause developmental abnormalities, particularly in fetuses and infants. The European Union and the state of California have announced restrictions on the presence of phthalates in children's products.

Congress has been working toward a new federal standard for lead in the substance of toys that, over time, would be tighter than the Toys "R" Us voluntary standard. In legislation that would expand the budget and authority of the Consumer Product Safety Commission (CPSC), would require CPSC to set a standard of "100 parts per million total lead content by weight for any part of the product, effective 4 years after the date of enactment of this Act, unless the Commission determines, after notice and a hearing, that a standard of 100 parts per million is not feasible, in which case the Commission shall require the lowest amount of lead that the Commission determines is feasible to achieve." (H.R. 4040 § 101(a)(2)(C) )

A version of the bill moving through the Senate, which the chamber may debate in the coming days, would make the 100 ppm standard effective 3 years after enactment. Both bills would set a lead standard of 90 ppm for the paint on toys.

Congressional action is needed, as President Bush continues to block CPSC from doing its job. One of CPSC's three commissioners resigned in 2006. Under the Consumer Product Safety Act, CPSC can continue to conduct formal business with two commissioners for six months. That quorum expired in January 2007, but in August Congress passed legislation extending the quorum another six months.

On Feb. 4, the quorum expired again. All the while, President Bush has refused to nominate a suitable candidate to serve as CPSC's third commissioner, even as concern over toy safety has found the national spotlight.



Posted by Matt Madia, 01:58:30 PM



Wednesday, February 20, 2008

One Year Later, White House Still Sitting on Whale Protection Rule

Today, a rule that would protect the North Atlantic right whale celebrates its one year anniversary of being stuck in the White House Office of Information and Regulatory Affairs (OIRA). Under Executive Order 12866, OIRA has 90 days to review regulations before they are finalized. In consultation with the issuing agency (in this case, the National Oceanic and Atmospheric Administration) OIRA may extend the review period by 30 days.

NOAA submitted the whale protection rule on Feb. 20, 2007. Therefore, OIRA has exceeded the review period by about eight months, and there is no end in sight.

The North Atlantic right whale is one of the most critically endangered marine species in the world. Although the species has benefited from federal protections for years, it is still having difficulty recovering. Collisions between whales and shipping vessels are a particularly serious problem.

In response, NOAA began working in 1999 on a federal rule to limit the speed of large shipping vessels traveling along the eastern seaboard. The speed limits would vary based on geographic location and season.

NOAA published a proposed rule (which OIRA also reviewed) in June 2006. Since receiving and reviewing public comments into early 2007, NOAA has been waiting for OIRA to give its approval.

OIRA may be delaying the rule to help out the shipping industry. In a May 3 letter to OIRA Administrator Susan Dudley, the World Shipping Council expressed opposition to the rule citing economic costs and questioning the validity of NOAA's research. The World Shipping Council represents some domestic but mostly foreign shippers.

The Ocean Conservancy has a timeline on the rulemaking and reported ship strikes of the right whale. According to the Ocean Conservancy, since NOAA published the proposed rule, there have been five reported ship strikes and three confirmed deaths.

While that may not sound like many, according to the Ocean Conservancy, "Only about 350 North Atlantic right whales are left, and the loss of even one whale is detrimental to the species."

The Ocean Conservancy also has an action alert on their website where you can send a letter to OIRA administrator Susan Dudley urging her to allow NOAA to finalize the rule. See the action alert here.



Posted by Matt Madia, 03:34:12 PM



At Lobbyist's Behest, FDA Pushes for Drug Marketing Loophole

The Food and Drug Administration is moving forward with a controversial new policy to allow pharmaceutical reps to market drugs for unapproved uses, despite objections from Congress and public health experts.

FDA doesn't just approve drugs, it approves drugs for specific uses. However, doctors can prescribe drugs for unapproved, or "off-label," uses.

Under a law that expired in 2006, pharmaceutical reps were legally able to distribute journal articles touting the benefits of off-label uses. But, according to the Associated Press, FDA maintained some regulatory oversight: "Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the articles' accuracy could be reviewed."

If FDA chooses to finalize this policy, which it published today as "proposed guidance," drug companies would be able to use journal articles to market off-label uses willy-nilly. The AP article continues, "Under the new proposal, drug companies don't have to submit articles."

Off-label use of drugs is big business. According to The Wall Street Journal, "[FDA] is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine."

According to Merrill Goozner at the GoozNews blog, the pharmaceutical lobby pushed for FDA to go forward with the policy which will be a boon for the industry:

So what was in today's proposed guidance? It pretty much gives industry everything it was looking for. It would allow drug salespersons to drop off article reprints as long as they came from a peer-reviewed journal that had a conflict-of-interest disclosure policy. Articles from industry-funded supplements would not be allowed…

Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research.

Rep. Henry Waxman (D-CA) caught wind of this policy last November and asked FDA to refrain from going forward. More on that here and here.



Posted by Matt Madia, 11:19:03 AM



Thursday, February 14, 2008

FDA Knew of Drug's Dangers, Failed to Stop Its Marketing

FDA's inability to ensure the safety of imported products is in the news again today. According to The New York Times, a plant in China, uninspected by FDA, is responsible for a contaminated ingredient in Heparin, a blood-thinning drug common in dialysis, heart surgeries and chronic care hospitals. At least four people have already died from using the drug.

Unlike some other dangerous import stories, this one isn't just about the inability of a federal agency to monitor imports; it's about flat-out negligence by FDA and by Heparin's maker, Baxter International. New York Times reporter Gardiner Harris has the story:

Public health officials noticed a problem with heparin supplies late last year when children undergoing dialysis at a Missouri hospital had severe allergic reactions. As officials investigated, they discovered hundreds of similar cases.

Baxter initially recalled some of the product, but the problems persisted.

The F.D.A. decided to allow Baxter to deliver heparin that it was in the midst of shipping for fear that a total recall would lead to an immediate and severe shortage of the drug. The F.D.A. cautioned doctors to use as little of the Baxter drug as possible and to infuse it into patients very slowly.

FDA and Baxter have known about the danger of Heparin for months, but, for most Americans, today will be the first they have heard of it.

Meanwhile, because FDA refused to stop Baxter shipments, users of Heparin were getting sick. According to an FDA press release, "About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007."

So instead of disseminating information that could have helped people, FDA chose to cover up the problem in the name of public health, even though hundreds were sickened and several died? Forgive Reg•Watch's cynicism, but could this be a case of FDA putting Baxter's corporate profits ahead of patients' safety?



Posted by Matt Madia, 11:12:55 AM



Monday, February 11, 2008

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Friday, February 08, 2008

Big Oil Looks to White House to Weaken Ozone Standard

Big oil is knocking on the White House's door looking for sympathy over an EPA proposal to tighten the national standard for ozone, aka smog. On January 25, representatives from ExxonMobil and the American Petroleum Institute met behind closed doors with officials from EPA and the White House Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA). (Frank O'Donnell at the Blog for Clean Air has the full story.)

EPA's bid to tighten the ozone standard (from the current level of 0.084 ppm to somewhere between 0.070 and 0.075 ppm) has raised the ire of many industry representatives and anti-regulatory lobbyists like the National Association of Manufacturers. Detractors of the proposed ozone-reduction rule claim it would impose big costs on polluters and result in economic hardships for companies, employees, and consumers.

There are two big problems with that argument. First, the Clean Air Act prohibits EPA from considering economic impact when regulating ozone. The Supreme Court has upheld the prohibition. EPA must use the best available science to set a standard that will protect public health, regardless of compliance costs.

Second, those who claim big costs are relying on a deeply flawed cost-benefit analysis prepared by EPA and OIRA. Cost-benefit analysis in public policy is rarely helpful, and EPA's ozone rule is a good example of just how ridiculous it can be.

For one of the options EPA is considering (0.070 ppm), the cost-benefit analysis concluded potential costs of $20 billion or potential benefits of $23 billion. How is anyone supposed to draw a meaningful conclusion from a $43 billion range?

Furthermore, ozone exposure can shorten lives. Therefore, reducing ozone pollution can help people live better and live longer. How can anyone put a price tag on that?

For a more detailed discussion, read a recent opinion column from OMB Watch available at OurFuture.org: "How Bush Undermines Government Regulation"

(For a really detailed discussion, read OMB Watch's report, Polluted Logic: How EPA's ozone standard illustrates the flaws of cost-benefit analysis.)



Posted by Matt Madia, 04:29:46 PM



Uncertainty over Plastics Chemical -- Legitimate or Contrived?

Rep. John Dingell's Energy and Commerce Committee recently began an investigation into the use and safety of bisphenol-A, a chemical commonly found in a host of consumer products including plastic bottles. In a Feb. 6 article, ABC News reporter Justin Rood provides an update on exactly what the committee has been looking into.

According to the article, Dingell is particularly concerned with the work of scientific consultants. The article discusses one of those consultants, the Weinberg Group, which may be designing its scientific research in order to produce conclusions about bisphenol-A that downplay the negative effects of the chemical: "The Weinberg Group may play a role in arranging just the kinds of expert panels and scientific research the chemical industry points to in defense of its products, Dingell suggested."

The charges against the Weinberg Group are similar to those made against Sciences International, a contractor who the National Toxicology Program was paying to investigate the effects of bisphenol-A on reproductive health. (More on that here.) The Weinberg Group is not listed as a recipient of federal contracts or grants, according to FedSpending.org.

The scientific uncertainty surrounding bisphenol-A for years has prevented meaningful government intervention. Not only has use of the chemical gone unabated in consumer products, the public is in the dark as to which consumer products might contain bisphenol-A and what the ramifications might be.

At the very least, the public deserves to know the full set of facts about bisphenol-A and the companies who use it.



Posted by Matt Madia, 11:06:49 AM



Thursday, February 07, 2008

Oil and Gas Companies Win, Polar Bears Lose

Last week, Reg•Watch blogged about two pending decisions at the Department of the Interior: one to list the polar bear under the Endangered Species Act (ESA), and one to allow oil and gas drilling in the Chukchi Sea off Alaska's coast.

Yesterday, Interior announced the first of the two decisions. According to The Washington Post, the department awarded "$2.6 billion in winning bids from companies seeking to drill for oil and gas in Alaska's Chukchi Sea." The polar bear decision is still pending, even though the statutory deadline for making the decision passed weeks ago.

Because of the convenient timing of the two decisions, oil and gas companies will not have to take special precautions to ensure the safety and health of the polar bear species in the Chukchi Sea — one of the polar bear's most important habitats. According to the World Wildlife Fund, "this lease sale is taking place before the ESA listing decision, allowing MMS to sell off polar bear habitat to the oil and gas industry without adhering to the protections of the ESA."

Related post: Polar Bear Trails Oil and Gas in Race to a Decision



Posted by Matt Madia, 10:57:34 AM




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