Thursday, March 10, 2011

A toxic consensus on toxic substances?

When ducks are in a row, stars align, and Republicans, Democrats, industry and environmentalists agree — it’s time to worry. Such forces materialized at recent congressional hearings where all parties echoed the need for “modernization” of the Toxic Substances Control Act (TSCA). Unfortunately, such “consensus” is likely to produce yet more red tape, reduced choice, stymied innovation, and increased public health risks.

Originally passed in 1976, TSCA is designed to ensure the safe use of industrial chemicals (excluding chemicals regulated on the federal pesticide and cosmetics laws) by granting the EPA authority to review both new and existing chemicals and to regulate any chemical that the agency found posed an “unreasonable risk of injury to health or the environment.” According to a 2007 Government Accountability Office (GAO) report, TSCA covers 82,000 chemicals, of which 62,000 were already in commerce when EPA began implementation in 1979. EPA has reviewed 45,000 new chemicals and has placed 20,000 in the inventory as those allowed in commerce, while restricting the use of five existing chemicals.

The various interest groups each have different motivations for supporting the “modernization” of this process. Industry largely supports TSCA reform for a very practical reason: their Washington lobbyists hope a revised federal toxics law will preempt the dozens of existing and proposed state laws around the nation. After all, it’s easier to follow one master than 50. “As of today, 30 states have introduced legislation. We would like one strong federal standard,” explained Phil Klein of the Consumer Specialty Products Association (CSPA) in a recent issue of CQ Weekly.

CSPA — a trade group representing a host of consumer products from cleaning detergents to bug spray — is part of a larger, industry coalition led by the American Chemistry Council that is pushing for TSCA reform with the hopes of gaining preemption. But there are very few instances in which federal environmental laws preempt state law; it almost never happens. Instead federal laws provide the floor — allowing states to impose more onerous standards in addition to federal standards. TSCA reform bills during the 111th Congress excluded preemption because opposition from environmentalists and state-level policymakers is strong.

Some Republicans support reform based on the idea that it could promote reasonable, science-based standards with a minimal economic impact. In a statement submitted at the hearing, Senator James Inhofe (R-Okla.) explained: “we can reach an agreement to develop a workable bill, one based on the best available science, one that protects human health, and one that balances the need to protect jobs and economic growth.”

But impetus for TSCA reform comes from the left’s desire to depart from hard science and cost-benefit considerations. Environmentalists and Democrats want to replace TSCA’s scientific-based standard with a political one based on the precautionary principle — a concept calling on regulators to act even in the absence of scientific justifications. A meeting of environmentalist activists formalized the concept in 1998 by issuing the so-called “Wingspread Statement” on the precautionary principle. It reads: “When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically.” Other formulations call on industry to prove their products “safe” before they can enter commerce, rather than demanding regulators prove otherwise before regulating.

Ironically, the precautionary approach is dangerous because it rarely considers the risks associated with the regulations themselves — or their economic impacts. Banning a product simply because it “might” pose a risk means replacing it with second-tier products that may pose higher risks, higher costs, or both. Moreover, misguided government bans simply waste the fruits of human labor and ingenuity employed to create the products. The mere threat of onerous regulation impedes innovation and entrepreneurship. Such policies stymie economic growth and eventually produce a lower standard of living for everyone.

Accordingly, those who value science and economic growth would be wiser to support TSCA’s existing “unreasonable risk” standard. The EPA explains on its website:
unreasonable risk involves the balancing of the probability that harm will occur and the magnitude and severity of that harm against the effect of a proposed regulatory action on the availability to society of the expected benefits of the chemical substance.

This standard encourages — if not demands — that the agency focus on scientifically robust, well-designed studies and demands cost-benefit considerations. Citizens should demand at least as much before any governmental body issues regulations that undermine the freedoms necessary for society to progress and innovate. But the greens are unhappy with this science-based standard, which is why TSCA reform is on the agenda in the first place. As the Safer Chemicals, Healthy Families — a coalition of left-of-center activists and greens — put it on their website:
Over the course of the 34 years since TSCA was enacted, EPA has succeeded in restricting only limited uses of five chemicals. The burden of proof TSCA places on the EPA to prove actual harm before it can regulate a chemical and to show its regulatory action is the least burdensome of all options is so onerous that it prevented the EPA from restricting asbestos, a known human carcinogen.

In reality, the court overturned the EPA’s total asbestos ban because the agency could not scientifically justify the regulation as TSCA (exposure and use of asbestos are regulated by Occupational Safety and Health Administration and other EPA regulations). The court opinion in Corrosion Proof Fittings v. EPAstated: “We conclude that the EPA has presented insufficient evidence to justify its asbestos ban. We base this conclusion upon two grounds: the failure of the EPA to consider all necessary evidence and its failure to give adequate weight to statutory language requiring it to promulgate the least burdensome, reasonable regulation required to protect the environment adequately.”

For example, the court noted that the EPA rule could have increased fatalities because the agency failed to consider the inadequacy of substitutes for asbestos used in automobile brakes. By signing on to misguided TSCA reform, industry and conservatives on the Hill are likely to repeat a colossal error they made in 1996 when they “modernized” the nation’s pesticide law.

During the 104th Congress, agricultural interests, chemical producers, and conservative Republicans worked with the left to replace the 1958-passed “Delaney Clause.” The Delaney Clause is a near zero-risk regulatory standard applied to pesticide residues found on processed food. Improved ability to measure pesticide levels at the time meant that the feds would have to start banning a number of products to meet the near zero-risk standard. The new law was supposed to save these products by replacing Delaney with a more reasonable “modern” standard for pesticides.

Republican and moderate Democrats from agricultural states as well as agricultural industry representatives argued that new law would allow for quicker pesticide approvals, fewer bans, and would help farmers produce a “safe and affordable” food supply. That’s not what happened. They passed the Food Quality Protection Act (FQPA), which set in place an overly precautionary standard. It demands that products meet a “reasonable risk of no harm” standard and employ numerous, other safety factors to ensure products are thousands of time safer than necessary to protect health. The new standard is arguably more stringent than the Delaney Clause. An article entitled “Wake-up Call” in California Farmerexplained shortly after FQPA became law:
No, you may not gain peace of mind when discovering that the new standard is stricter than Delaney, at least the way EPA and FDA was interpreting it […]. Delaney was interpreted as posing a one in a million chance of additional cancer cases from all crop uses of a pesticide. The new, tougher standard — “a reasonable certainty of no harm to sensitive populations” — applies to all pesticides, not only cancer-causing ones.

Ironically, the FQPA is one of the models that greens would like TSCA reform to follow — despite the fact that it has proven disastrous. Under the FQPA, the EPA has banned and restricted the use of thousands of pesticides — the opposite of what lawmakers desired. In 2006, for example, the EPA completed a 10-year study of 230 organophosphates and carbonates pesticides. It concluded FQPA standards demand that the agency ban 3,200 uses of pesticide products in these categories alone and place restrictions on 1,200 other uses. It deemed 5,237 uses as “safe” under the act. Meanwhile, pest problems are on the rise as fewer and fewer pesticides are available or under development. Many cities around the nation, for example, are scrambling for solutions to bed bug problems in hotels, retirement communities, schools, stores, and homes — but there are few products left to control them. TSCA reform is heading down the same path, and if enacted will promote more precautionary legislation for EPA programs as well as at other federal agencies. In fact, the activists pushing TSCA reform are also pushing precautionary policies elsewhere. In particular, the Campaign for Safe Cosmetics wants the FDA to dispense with science in favor of caution, and precautionary chemical legislation is moving in 30 states — as noted on the activist website saferstates.com.

Margaret Thatcher once explained that “consensus seems to be the process of abandoning all beliefs, principles, values and policies.” The Iron Lady was right about many things, this included; principled lawmakers should heed her warning now.

SOURCE






Pharmacies selling 'quack' health products, CHOICE investigation reveals

AUSTRALIAN pharmacists have been called out for including "quack" healthcare products on their shelves. A CHOICE review of items commonly sold through pharmacies has uncovered a range of products that have purported health benefits but "no credible evidence that they work".

These included ear candles, herbal weight loss remedies and plastic bracelets with a hologram sticker which claim to improve balance, muscle strength while alleviating jet lag and motion sickness.

"Antisnor" rings - a metal ring worn on the little finger - were also for sale despite the Australian Competition and Consumer Commission (ACCC) taking action against its manufacturer to halt its claims it could actually prevent snoring.

"There is an onus on pharmacies to sell products that work and for pharmacists to stand by the safety and effectiveness of products in their store," said CHOICE spokeswoman Ingrid Just. "Pharmacists hold a four year specialist degree in chemistry, and consumers rely on their expert advice."

CHOICE also raised concern about homeopathy remedies appearing in pharmacies, stating the question of whether they had any real effect on the body had been "long debated (and) systematic reviews of clinical trials say no".

Ms Just said many pharmacies had expanded their offerings and they now resembled "full blown retail enterprises" selling "all manner of things from from toilet paper and confectionary to cosmetics and sunscreens".

This was not an issue, she said, where items for sale did not have a therapeutic of health claim attached to them. "But when it comes to health products, they should stick to selling ones that are safe, effective and supported by scientific and clinical evidence," Ms Just said.

The CHOICE probe also asked pharmacists about the efficacy of certain products and some offered "insightful, medically sound advice when asked." Others were "indifferent or who gave advice on quack products with no scientific or medical basis".

Ms Just said the problem was consumers could find themselves out of pocket, and with no relief for the problem they are seeking help for. "When products don't work the consumer may not only have wasted their money, they may have also delayed the opportunity to seek more appropriate treatment," she said.

CHOICE said people should, when considering a new or novel health product, ask their pharmacists if there was any evidence supporting its use.

The Pharmacy Guild of Australia agrees. "Pharmacists take their professional responsibilities very seriously," a guild spokesman told AAP. "The guild agrees with CHOICE's recommendation that the best course of action is to speak to the pharmacist about any new or novel product you're considering, and ask for further information."

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