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Monday, May 16, 2005

Unified Agenda out today
The semiannual Unified Agenda is available in today's Federal Register. It will eventually be available in database form on this site; until then, here are links to the PDFs of the agendas for certain key agencies:

Posted by Robert Shull, 04:56:01 PM

Sunday, May 15, 2005

New agency agendas
BNA's Daily Report for Executives (a subscription-only service) has already combed through a copy of tomorrow's edition of the Federal Register, in which the agencies are releasing their semiannual agendas for the next six months of regulatory priorities. We have some information available to help people decipher the agendas: click here for more.

Posted by Robert Shull, 02:53:03 PM

Tuesday, May 10, 2005

OIRA, Industry Meet over MSHA's Asbestos Rule
The Office of Information and Regulatory Affairs and the Mine Safety and Health Administration have met with representatives from the National Stone, Sand and Gravel Association over an MSHA proposed rule governing asbestos. According to MSHA's Regulatory Plan, released in December, the agency is planning on reducing the permissible exposure level for asbestos in an upcoming rulemaking.

Posted by Genevieve Smith, 05:13:00 PM

EPA Halts Rulemaking to Prevent Childhood Lead-Poisoning
According to a letter from several minority representatives to EPA Administrator Stephen Johnson, EPA has decided to stop work on a regulation to protect children and construction workers against lead poisoning from building renovation and remodeling. Instead the agency plans to allow construction companies to voluntarily comply with standards.

Lead is a known neurotoxin that particular harms children. Renovation and remodeling, which can release lead-based paint chips or dust into the air, is one of the largest sources of lead exposure. Under the Toxic Substances and Control Act, EPA is required to promulgate rules to protect children, families and construction workers from home exposure to lead. EPA may be breaking the law by failing issue this important regulatory protection. Rep. Henry Waxman and Sen. Barbara Boxer have written a letter to Johnson asking for an explanation of EPA's apparent abandonment of this regulation and encouraging EPA to resume the rulemaking. From the letter:

A briefing paper entitled "U.S. Environmental Protection Agency Lead Safety Program Voluntary Initiative, Briefing for the Deputy Administrator, May 19, 2004," reveals that [Johnson was] presented with a choice as to whether to complete the rule or to pursue an alternative approach. The alternative was a plan to merely encourage lead-safe remodeling and renovation practices through a voluntary, collaborative program for contractors engaged in remodeling and renovation in housing with lead paint. This alternative would begin with a pilot program that would involve a small number of contractors in just two cities.
After this briefing, EPA apparently stopped work on the rule in favor of the voluntary approach. EPA's next regulatory agenda, published in June 2004, dropped the renovation and remodeling rule and added a "Voluntary Program for Renovation and Remodeling." EPA's fall 2004 regulatory plan states, "As an alternative to the regulatory program, EPA is working with stakeholder to develop a voluntary program for renovations and remodeling activities." The voluntary program was supposed to "partner the Agency and national organizations together to promote an initiative which could provide incentives to participating contractors and property owners who incorporate lead safe work practices into their standard operating procedures."

Unlike a regulation which can be enforced by EPA and applies across the board, voluntary guidelines let construction companies who fail to comply off the hook. More from the letter:

In addition to violating the requirements of the law, a voluntary approach will fail to protect children from the health effects of lead. A voluntary approach is unenforceable, is unlikely to be effective, would take years to implement, and requires substantial new funding that is simply not provided for in EPA's budget.
EPA has identified lead safe work practices that will greatly reduce exposures. Under a voluntary approach, there would be no requirement to use these practices and no ability to enforce them. Given the serious and ongoing threats to children from lead poisoning in renovated homes, taking minimal protective actions should not be optional. This is why Congress required EPA to promulgate regulations to address this problem.

Protecting children's health is not a voluntary matter. Email Stephen Johnson and tell him how you feel about EPA's abandonment of this regulatory protection of childhood lead-poisoning.

Posted by Genevieve Smith, 04:24:57 PM

Friday, May 06, 2005

Swimming upstream into risky territory
Instead of hit lists and regulatory sunsets that would weaken or eliminate the protections we need, why isn’t our government doing its part to address the public’s unmet needs? Latest case in point: farm-raised fish.

Two articles appearing the same day raise concerns about the potential harms of farm-raised salmon. One article stresses the ecological harms and calls for assessments of those risks:

The substantial risk to salmon stocks posed by salmon that escape from net-pen farms argues for risk assessments of all types of marine fish farming, according to an article published in BioScience.
Rosamond Naylor of Stanford University and nine coauthors conclude in their article that without a firm policy mandate for risk assessment of escaping farm fish, aquaculture will "almost certainly lead to extensive competition between wild fish and continuously released farm fish--or widespread establishment of exotic fish species--and thus to a further decline in wild fish stocks."
Naylor and her coauthors conclude that, despite some efforts by aquaculture companies to curtail farm salmon escapes--such as using stronger net materials-- the efforts are inadequate, as monitoring and enforcement of regulations governing escapes are weak. An estimated two million farm Atlantic salmon escape each year into the North Atlantic, and millions more have escaped on the western coasts of North American and South America. Farm Atlantic salmon are more aggressive and faster-growing than native fish, with which they compete for food.
Interbreeding with native salmon stocks leads to long-term loss of fitness and productivity in wild populations and threatens their genetic diversity.
Moreover, farmed salmon appear to have transmitted parasites and infections to wild stocks. Escaped farm salmon are now successfully breeding in the wild in Norway, Ireland, the United Kingdom, and North America. Incipient feral Atlantic salmon populations have been found in rivers in British Columbia and South America.

Meanwhile, another article stresses the dangers to human health:

It’s been known that farmed salmon fish contains high levels of PCBs and PBDEs. Now a study warns that farmed salmon is also contaminated with dioxins, another cancer-causing agent.
Consumption of farm-raised salmon poses greater health risks from dioxin and dioxin-like compounds than does the consumption of wild salmon, according to a study published in the May 2005 issue of the peer-reviewed journal Environmental Health Perspectives.
Dioxins, pollutants associated with numerous adverse health effects (most notably cancer but also extending to suppression of the immune system, learning disabilities, increased risk of cardiovascular disease, impaired prostate development, and endometriosis), have been reported to be present at higher levels in farmed salmon, possibly resulting from the levels of dioxin-like compounds (DLCs) and other organic contaminants in the feed.
Although the study authors acknowledge recommendations from the National Academy of Sciences Institute of Medicine and the American Heart Associations that frequent consumption of fish is beneficial, the authors suggest that the risk of cancer and other health effects may outweigh the benefits that some types of seafood offer. Women who become pregnant may be at increased risk due to the effect of the toxicants on developing fetuses.

For related information, check out Public Citizen’s work on issues related to other farm-raised seafoods.

Posted by Robert Shull, 12:03:54 PM

Thursday, May 05, 2005

Fetal harm, culture of life, and unsound science
Scientists have concluded that male fetuses exposed to very low doses of man-made estrogenic chemicals commonly found in drugs and consumer products are at risk of developing deformities in the prostate and the bladder. A study in the Proceedings of the National Academy of Sciences looked at a drug used in oral contraceptives (important because every year about 3% of women taking birth control pills unknowingly become pregnant, typically because of lapsed doses, and continue to use the pill during the first few months of pregnancy) and at bisphenol A, an estrogenic chemical used to manufacture polycarbonate plastic, some dental sealants, and the resin lining of most food and beverage cans.

Interesting note: BNA’s Daily Report for Executives interviewed one of the study’s authors, who also conducted a literature review of 115 published studies of bisphenol A. “Every single study of bisphenol A conducted with industry funds finds the softener to be safe, while nearly every study conducted without industry funds finds bisphenol A to cause problems, sometimes severe ones, Vom Saal said, comparing the situation to research on tobacco.”

The authors explained that they conducted the study with low doses rather than high ones, because it is “now well known that hormones can have opposite effects at low vs. high doses. Studies that include only very high doses of drugs or chemicals can miss unique effects that are observed only within a physiologically relevant low dose range.”

Second interesting note, from BNA:

EPA said very low doses of chemicals and pesticides would not be used routinely in laboratory analysis to detect endocrine disruption.
If chemical-specific data suggest that very low doses should be used when evaluating a particular chemical or pesticide, the agency will consider on a case-by-case basis using very low doses, said Vanessa Vu, then the director of EPA’s Office of Science Coordination and Policy.

We’ll just let that speak for itself.

More information:

Barry G. Timms, Kembra L. Howdeshell, Lesley Barton, Sarahann Bradley, Catherine A. Richter, & Frederick S. vom Saal, Estrogenic Chemicals in Plastic and Oral Contraceptives Disrupt Development of the Fetal Mouse Prostate and Urethra, 102 Proc. Nat’l Acad. Sci. 7014 (2005)
Pat Phibbs, Male Mice Harmed in Study on Bisphenol-A But No Definite Link to Humans Established, Daily Rep. Execs., May 3, 2005, at A-34.

Posted by Robert Shull, 04:04:33 PM

Using abused and neglected children as guinea pigs
The AP is reporting that government-funded researchers have been testing AIDS drugs on abused and neglected children in foster care, for the last two decades—without providing those children the protections they are supposed to have under federal law and some states’ laws:

Several studies that enlisted foster children reported patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections.
In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage.

There may be an even larger, more disturbing pattern of using the nation’s abused and neglected children in foster care as guinea pigs—or, worse, as a vulnerable population caught up in a system typically staffed by undertrained workers who are more interested in controlling them than caring for them, which makes the system and its Medicaid dollars easy pickings for giant pharmaceutical corporations always looking out for reliable markets for their products.

The state of Florida, for example, is just recovering from a scandal over the doping of abused and neglected children in its child welfare system. According to the Miami Herald, “as many as one in four foster children were being given psychiatric drugs, sometimes large ‘cocktails’ of such medications.” The state legislature has just passed a law forbidding the foster care system from consenting to psychoactive prescriptions unless the child’s birth parents or a juvenile court judge approves the drug.

The furor over psychiatric drugs began in February 2001, when Coral Springs attorney Andrea Moore told child welfare officials that two of her clients had developed severe side effects as a result of taking an anti-psychotic drug, Risperdal. One girl began lactating, though she wasn’t pregnant.
When Moore questioned the use of the drugs on children who were not diagnosed as psychotic, “doctors responded by changing the diagnosis to include either a psychosis or modified an existing diagnosis to include psychotic features, thereby ‘justifying’ administration of the drug,” Moore wrote in a February 2001 letter.
Three months later, The Herald reported that a consultant hired by DCF warned that “the widespread use of psychotropic medications is a systemwide issue” in the state’s child welfare program.

Florida is not alone:

In Texas, Dr. John Breeding, an Austin psychologist, has seen cases where some foster children were placed on as many as 17 drugs and says drugs are being used as chemical restraints in Texas. He wants all SSRIs and neuroleptic drugs banned from use on children. “The SSRIs are extremely harmful and addictive and can cause or exacerbate suicidal or homicidal tendencies; withdrawal is painful and dangerous,” Breeding warns.

Meanwhile, as the Online Journal reports, the Bush administration is promoting a scheme designed by the New Freedoms Commission on Mental Health to conduct mental health screenings for all teens before they graduate from high school. Some see this effort as a way to give pharmaceutical companies access to even more children:

Despite the fact that SSRI antidepressants are banned for use in children in the UK and despite the FDA "black box" warning label now required on all SSRIs that the drugs increase suicidal thinking and behavior in kids, the NFC not only recommends that the same drugs be prescribed to children, it promotes the very schemes that will increase the number of kids on these drugs in schools and other public institutions.

The answer to the problem could be some combination of enforcing current federal law and setting in place tougher requirements for states taking federal foster care dollars to make sure that they are adequately protecting the abused and neglected children in their care. But wait a second: developments in Congress could shut down that option before it is even tried. Republican lawmakers and representatives of state and local governments are considering expanding the Unfunded Mandates Reform Act to make it difficult—and potentially impossible—to set such requirements for the states. One of the fundamental purposes of federal child welfare spending is to use the carrot of federal dollars to induce states to protect children in their care to a level that they just weren’t doing on their own. Although UMRA currently excludes funding conditions and entitlements, such as federal foster care funds, from its coverage, state and local government groups actually want foster care and the rest to be brought in UMRA’s scope.

Doping abused and neglected children in foster care—and using Medicaid to pay for it. Another reason that “mandates” matter, and that changing UMRA is a bad, bad idea.

Posted by Robert Shull, 01:04:09 PM

Sunday, May 01, 2005

How yummy is Listeria?
The House Small Business Committee recently debated the White House’s hit list of regulatory protections to be weakened or eliminated. That hit list includes, among its many targets, the weakening or elimination of the USDA interim final rule to protect us against Listeria, even though many more ready-to-eat meat products continue to be recalled because of Listeria concerns:

Why is the Listeria rule on the hit list, given that the Bush administration already weakened the standard from a tougher standard proposed by the Clinton administration? The rash of recalls may well be evidence that the current standard is working as is and needs to be strengthened, if anything, but not weakened. The administration appears to be using the problems of the manufacturing sector and small business as an excuse to weaken our protections and aid its supporters in big corporations.

Posted by Robert Shull, 07:02:21 PM

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