Regulatory Policy - RegWatch

RegWatch:

News & Analysis | REG•WATCH Blog | Press Room

Thursday, March 27, 2008

Industry Directed FDA Policy on Plastics Chemical

The House Energy and Commerce Committee's investigation into the use of Bisphenol-A — a chemical substance common in plastics and in the lining of food cans — continues to turn up startling information. The Food and Drug Administration (FDA) says Bisphenol-A is safe, but studies have shown the chemical is associated with a host of adverse health effects including breast and prostate cancer, according to the Environmental Working Group.

The committee wrote to FDA in January asking the agency to identify the studies it used to make its determination that Bisphenol-A does not pose a "safety concern at the current exposure level." In response, FDA identified two studies. Both studies were funded by industry and were absent the usual scientific rigor characteristic of regulatory decision making, according to The Milwaukee Journal-Sentinel.

The Journal-Sentinel has the full story:

In response to a congressional inquiry, Stephen Mason, the FDA's acting assistant commissioner for legislation, wrote in a letter that his agency's claim relied on two pivotal studies sponsored by the Society of the Plastics Industry, a subsidiary of the American Chemistry Council.

One of the studies has never been published, and therefore never subjected to peer review; the second has been heavily criticized by researchers who say the results are inconclusive because of flawed experimental methods….

According to the letter, the FDA based its claim that there is no "safety concern at the current exposure level" on its own studies, conducted in the 1990s, which indicated that people were exposed to small amounts of the chemical.

They gathered that information by testing products such as aluminum cans and baby bottles to see how much of the chemical was leaching. Then they looked to the two chemical industry studies to see if those exposure levels could cause harm.

The two studies said the chemical caused no harm to rodents at low doses.

Posted by Matt Madia, 11:04:07 AM

Tuesday, March 25, 2008

On Toy Safety, States Lead the Way

Wall Street Journal reporter Joseph Pereira writes today about state government efforts to limit the presence of certain substances in children's toys, particularly lead. Both the U.S. Congress and U.S. Consumer Product Safety Commission (CPSC) have been unable to quickly enact policies to respond to public concern over toy safety.

Numerous past congresses and presidents have allowed CPSC's budget and staffing levels to whither. As a result, the agency is unable to handle the rising tide of imported products on our store shelves. In the light of last year's record number of toy recalls and growing public concern, state legislatures and administrations have grown impatient:

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…

The article breaks down toy standards in a handful of states that have chosen to pursue legislation or regulation stricter than federal requirements. Two notable substances which have become the target of regulation are lead and phthalates, a chemical used to soften plastics which studies have associated with developmental abnormalities.

Because of the differences among state standards, industry lobbyists are now complaining about the multiple requirements toy makers will have to meet. In the article, Carter Keithley, the president of the Toy Industry Association (TIA), the national lobbying arm for toy makers, says, "Having different standards for different states is just going to create complete chaos." The article also reports, "The TIA says it has hired lobbyists to battle legislative proposals in 10 states."

However, regardless of states' efforts, toy makers will find it harder and harder to sell their products to major retailers if those products contain phthalates or more than trace amounts of lead. Toys "R" Us has announced it will enforce a standard for lead in toys sold at its stores that will be stronger than the federal standard. The retailer has also announced it will phase out phthalates in its products by the end of the year. Target Corp. told The Wall Street Journal it will eliminate the use of phthalates in Target brand toys.

The TIA supports bills in both the U.S. House and Senate that would tighten the federal standard for lead and provide more resources for CPSC. TIA does not support standards for phthalates, claiming there is "no solid, scientific evidence that any person has ever been harmed by the presence of phthalates in toys." (Click here for TIA statements.)

Ultimately, getting lead, phthalates, and other harmful substances out of toys will be a great victory for consumers. But we should also take note as to who guided us on that path to victory. Instead of the federal government leading the way, strong action by concerned states and responsible retailers has relegated Congress and CPSC to mere followers.

Posted by Matt Madia, 02:26:36 PM

Friday, March 14, 2008

Dudley Uses Ozone Rule to Advance Industry Interests and Anti-Regulatory Ideology

The White House's interference in EPA's revision to the national standard for ozone, a.k.a. smog, which the agency announced Wednesday, ignores public health and welfare. OIRA Administrator Susan Dudley, with President Bush in her corner, pushed forward with her industry friendly, anti-regulatory ideology in the face of overwhelming scientific evidence and in violation of the law.

Read more

Posted by Matt Madia, 02:51:26 PM

Thursday, March 13, 2008

Bush, Cheney, and OMB Leave Fingerprints on Smog Standard

Yesterday evening, EPA announced its long-awaited decision on the national standard for ozone, a.k.a. smog. As expected, EPA chose to tighten the primary standard to 0.075 parts per million (ppm) from its current level of 0.084 ppm. The secondary standard for ozone will remain identical to the primary standard.

EPA's Administrator, Stephen Johnson, is now taking heat from both sides. Industry groups like the National Association of Manufacturers complain the rule will levy large compliance costs — ignoring the Clean Air Act's prohibition on considering economics for ozone standards. Environmental and public health advocates complain EPA ignored the advice of its independent scientific advisers (who had recommended a standard between 0.060 and 0.070 ppm) and that the rule is not adequately protective of public health. For a breakdown of how the public could have benefited from a tighter standard, see this press release from Environmental Defense.

EPA's decision to tighten the ozone standard will go down as one of the biggest environmental policies to come out of the Bush administration. To prove the significance of the rule, simply look at who was involved.

While EPA's decision to set a standard of .075 ppm had been a foregone conclusion, but officials wrangled over whether to set a separate secondary standard. Under the Clean Air Act, EPA may set a secondary standard for the protection of public welfare. (The primary standard is to focus on public health.)

In the past, EPA has chosen not to set a secondary standard for ozone; but during this revision, the agency had prepared to set a more tailored, seasonal standard citing the vulnerability of certain plants sensitive to ozone's deleterious effects.

However, just days before EPA was ready to issue the new primary and secondary standards, Susan Dudley — the administrator of OMB's Office of Information and Regulatory Affairs who President Bush recess appointed last April — wrote to Johnson March 6 complaining EPA had not considered economics in proposing a new secondary standard and raising questions about the scientific justification for the decision.

Marcus Peacock, EPA's Deputy Administrator and Regulatory Policy Officer, shot back in a letter dated March 7. Peacock said EPA is prohibited from considering costs in setting the secondary standard, and that the agency had provided ample scientific rationale for its decision. An internal memo dated March 11 shows EPA was ready to ignore Dudley's complaints and set a new seasonal secondary standard for ozone.

Apparently, that's when the head honcho stepped in. According to Washington Post reporter Juliet Eilperin, "The rule's preamble indicates Bush settled the dispute March 11, saying the president concluded the secondary standard should be set 'to be identical to the new primary standard, the approach adopted when ozone standards were last promulgated.' "

The president's direct intervention in a rulemaking is rare and, in this case, damaging. The Decider at work.

Johnson's decision to ignore the advice of his scientific advisers and set a compromise standard of .075 ppm likely comes in response to pressure from industry groups and anti-regulatory lobbyists who didn't want the standard changed at all. In the months leading up to the decision, EPA and OMB held numerous closed-door meetings with representatives from the oil, electric, and auto industries, among others.

One of those meetings, held way back in June to hear the specific complaints of the auto industry, featured a representative from the office of Vice President Dick Cheney. Cheney's office rarely involves itself in specific rulemakings; but when it does, it focuses on high-profile rules, particularly environmental and homeland security rules. Although the details of the meeting are not public, the vice president's office was probably stumping on behalf of Big Auto, and against the public health.

Posted by Matt Madia, 11:13:49 AM

Monday, March 10, 2008

Polar Bear Indecision Will Be Investigated

The Department of Interior's inspector general is conducting a preliminary investigation into the Department's continuing delay of a decision to protect the polar bear, according to the Associated Press. Interior's Fish and Wildlife Service (FWS) missed a January deadline to decide whether to list the polar bear under the Endangered Species Act.

The inspector general's office opened the investigation in response to complaints from environmental groups, AP reports. Interior officials may have missed the deadline intentionally as a favor to the oil and gas industry. In February, another agency in the department awarded "$2.6 billion in winning bids from companies seeking to drill for oil and gas in Alaska's Chukchi Sea," according to The Washington Post.

Because Interior delayed the polar bear decision, 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 [Interior] to sell off polar bear habitat to the oil and gas industry without adhering to the protections of the ESA."

This is not the first time Interior's inspector general has looked into political manipulation of endangered species decisions. In March 2007, the inspector general's office exposed Julie MacDonald, an FWS employee who had been ignoring scientific findings calling for species protections and leaking internal documents to industry lobbyists. MacDonald resigned amid the ensuing fallout.

The inspector general will decide whether to conduct a full-blown inquiry based on the preliminary investigation.

Posted by Matt Madia, 01:25:47 PM

Friday, March 07, 2008

Bush Administration to Alter Employee Leave Protections

The Department of Labor (DOL) has announced a proposed rule that would alter federal protections for workers who need to take leave to care for themselves or their families. DOL chose to pursue the rule changes after hearing complaints from industry lobbyists.

The Family and Medical Leave Act of 1993 (FMLA) allows employees to take up to 12 weeks of unpaid leave in a 12-month period without risking their pay, benefits, or position. According to DOL, employees can apply for FMLA leave "for the birth of a child; for the placement of a child for adoption or foster care; to care for a newborn or newly-placed child; to care for a spouse, parent, son or daughter with a serious health condition; or when the employee is unable to work due to the employee's own serious health condition."

According the National Partnership for Women and Families, a nonprofit organization that works on workplace fairness issues and has expertise on FMLA, several provisions in the proposed rule would make it more difficult for workers to take FMLA leave.

Read more

Posted by Matt Madia, 10:06:45 AM

Thursday, March 06, 2008

Countdown to the Disappointment: The Final Days of Ozone Lobbying

Groups representing both industry and the public are making final efforts to lobby EPA on its upcoming revision to the national standard for ozone, a.k.a. smog. EPA is under a court deadline to finalize the new standard by March 12.

EPA's scientific advisory panel on clean air has recommended EPA tighten the standard (currently 84 parts per billion) to between 60 and 70 parts per billion — a recommendation most environmentalists and public health advocates endorse. Many industry groups, as well as some governors and some in Congress, would like the standard to remain the same.

EPA is leaning toward a standard of 75 parts per billion, the Associated Press reports:

Both industry lobbyists and environmentalists say they believe [EPA Administrator Stephen] Johnson has taken the view that the standard should be tightened to 75 parts per billion — an approach that doesn't satisfy either industry or health experts

"It's a political compromise," says Frank O'Donnell, president of Clean Air Watch, an advocacy group. Even so, he adds, "every major industry is ... putting the squeeze on" to get the White House to leave the current standard in place.

On Feb. 27, EPA and the White House Office of Management and Budget (OMB) met with lobbyists from the National Association of Manufacturers (NAM), the Edison Electric Institute, and the National Paint and Coatings Association. EPA and OMB also got a Valentine's Day visit from the National Taxpayers Union, an anti-government group that calls environmental, worker safety, and other public protections "hidden taxes." EPA and OMB have also heard complaints from big oil about a new ozone standard.

According to AP, "NAM Vice President Keith McCoy said his group told the White House Office of Management and Budget that the EPA was not considering the economic impact."

If it's true that EPA isn't considering economics, it's in an attempt to obey the law. The Clean Air Act prohibits EPA from considering compliance costs when setting the standard for ozone, and calls for the agency to make decisions that "reflect the latest scientific knowledge."

To their credit, on March 3, EPA and OMB met with representatives from NRDC, the American Lung Association, the American Academy of Pediatrics, and other public health groups. Those groups provided a listing of recent epidemiological studies that show adverse health effects at low levels of ozone exposure.

One of those adverse health effects is premature death, as AP also points out. A 2006 study for California showed that tightening the standard to 70 ppb would result in 270 avoided premature deaths in the state. "Another study estimated 3,800 premature deaths would be avoided nationwide."

For more on why EPA should base its decision on science, not economics, see the OMB Watch report Polluted Logic.

Posted by Matt Madia, 01:00:30 PM

Latest Entries by Theme

Cost-Benefit Analysis

In Congress

Publications