Sunday, September 6, 2009

Are the Obama Administration and the US Congress Foolish Enough to Impose the Harsh Costs of the European REACH Regulation on America?

The following article confirms prior ITSSD research about the exhorbitant costs associated with the European Union's regional adoption of the European Precautionary Principle-based REACH regulation, and its global efforts to export this philosophical and legal requirement abroad, including to the United States.

[See: Lawrence A. Kogan, The Extra-WTO Precautionary Principle: Once European 'Fashion' Export the U.S. Can Do Without, 17 Temple Political and Civil Rights Law Review 491 (Sept. 2008) accessible at: ; Has Barack Transformed Himself into EURObama Given His Interest in Adopting as US Law the Well-Known EU REACH Green Regulatory Trade Barrier??, ITSSD Journal on Disguised Trade Barriers (June 12, 2008) at: ; WTO 'Fever' Necessary to Stem Advance of Precautionary Principle 'Virus', Says ITSSD, PR Newswire (March 27, 2007) at: ; Lawrence A. Kogan, REACH: The fight must go on, Viewpoint: Specialty Chemicals Magazine (March 2007) at: ; Precautionary Principle Will Run in Place in 2007, Trade Expert Predicts, Interview With ITSSD President Lawrence A. Kogan (Jan. 2007) at: ; ob Spiegel, American Trade Groups Call REACH Misguided, DESIGN News (Dec. 27, 2006) at: ; EU REACH Adoption Likely to Trigger WTO Action, ITSSD PR Newswire (Dec. 15, 2006) at: ; Lawrence A. Kogan, REACHing for Your Wallets or Your Lives, ITSSD (Dec. 15, 2006) at: ; Chresten Andersen, Will Bad EU Policies REACH America? Brussels Journal (Nov. 19, 2005) at: ; Lawrence A. Kogan, Exporting Precaution: How Europe's Risk-Free Regulatory Agenda Threatens American Free Enterprise, Washington Legal Foundation (Nov. 2005) at: ; Lawrence A. Kogan, Precautionary Preference: How How Europe Employs Disguised Regulatory Protectionism to Weaken American Free Enterprise, International Journal of Economic Development Vol. 7 No. 2-3 (2005) at: and ; Lawrence A. Kogan, Exporting Europe's Protectionism, The National Interest Journal (Sept. 2004) at: ;Lawrence A. Kogan, Claims of Improper U.S. Lobbying Quite a REACH, EU Reporter (May 2004) at p. 18, at: ; Lawrence A. Kogan, 'Enlightened' Environmentalism or Disguised Protectionism: Assessing the Impact of EU Precaution-based Standards on Developing Countries, National Foreign Trade Council (April 2004) at: ; Lawrence A. Kogan, Unscientific "Precaution": Europe's Campaign To Erect New Foreign Trade Barriers, National Foreign Trade Council (Sept. 2003) at: ; Lawrence A. Kogan, Looking Behind the Curtain: The Growth of Trade Barriers that Ignore Sound Science, National Foreign Trade Council (May 2003) at: ]


REACH Program May Carry Six Times the Expected Cost

Sep 3, 2009

By: Stephanie Sutton

ePT--the Electronic Newsletter of Pharmaceutical Technology

Implementing Europe’s Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) program will require a massive increase in animal testing and cost six times more than previously estimated. The findings come from an analysis conducted by researchers at the John Hopkins Bloomberg School of Public Health (Baltimore, MD).

"REACH expected that 27,000 companies would submit 180,000 preregistrations on 30,000 chemicals,” Thomas Hartung, a Doerenkamp-Zbinden professor, chair for evidence-based toxicology, and director of the Center for Alternatives to Animal Testing at the Bloomberg School of Public Health, explained to Pharmaceutical Technology Europe (PTE). “The big surprise, however, was that at the end of December 2008, 65,000 companies had submitted 2.7 million preregistrations on 143,000 chemicals." Hartung co-chaired the 7th World Congress on Alternatives & Animal Use held in Rome earlier this week.

In a press statement, Hartung described REACH as the "biggest investment ever into consumer safety." However, he also believes that the scale of the challenge may have been underestimated. REACH could require 54 million research animals and EUR 9.5 billion ($13.5 billion) during the next 10 years. Approximately 90% of the projected animal use and 70% of the projected cost would come from research into reproductive toxicity testing. Usually, data must be collected from two generations of two species of animals.

Hartung explained to PTE that the second species is rarely used when testing chemicals because few new chemicals are produced at quantities high enough to trigger testing. "This is now different with REACH where the high-production chemicals are tested; so while only 70 two-generation studies were conducted over 25 years for industrial chemicals in the EU, we calculated 14,000 for REACH if the guidance to industry is followed," he said.

He added that, "European regulators need to understand that this is not only about animal numbers, but mainly about feasibility. It is not possible to create the test facilities. We do not have the toxicologists—a two-generation study assesses 80 endpoints, including complex histopathology. Our analysis should not be misread as a pure ethical or financial concern—it is about a bottleneck identified for a program we want to happen."

So what are the alternatives? Hartung suggests testing only suspicious chemicals. "Currently, the main trigger is production volume; at least prioritize the suspicious substances and leave the others for later when high-throughput strategies are developed," he says. He offered additional options, including the use of an extended one-generation study and in vitro approaches.

According to Hartung, 80–90% of the classifications of chemicals in two-generation studies are based on testing toxicity for which promising tests do exist.

"We hope that our study helps to gain momentum for a revision of current practices in regulatory toxicology," Hartung told PTE. He also explained that Europe could benefit from a development similar to the US Environmental Protection Agency toxicity testing strategy, which came into force in March 2009.


New Jersey Senator Frank Lautenberg and California Congressman Henry Waxman Wish to Adopt EXPENSIVE EU REACH Regulation as U.S. Federal Law
Obama Administration Suspends CHAMP Chemical Assessment Program
By Christine Lepisto
June 21, 2009
Only a few months ago, EPA Administrator Lisa Jackson announced that the U.S. Environmental Protection Administration would pick up the pace of the Chemicals Assessment and Management Program (CHAMP), partly in response to the barrage of activity in the EU under REACH (Registration, Evaluation and Authorization of CHemicals). Now the EPA has thrown Industry and Citizens into confusion with an announcement that all activity to screen and prioritize hazardous chemicals under CHAMP is to be suspended, effective immediately. How is it possible the EPA finds doing nothing better than doing something -- especially in the face of increasing concerns about the chemicals in our bodies, and even in the everyday products sold for our kids? And how long before EPA is doing something again?

Insiders Mulling Over ImpactsThe insiders, BNA and ChemicalWatch, are both reporting that EPA has released an announcement on the end of CHAMP. But even industry professionals are left in the dark, as no announcement has been made publicly available at the websites of CHAMP, the EPA, nor the White House blog.

Major organizations have responded cautiously to the announcement. Some statements published in Chemical & Engineering News:

"We are confident that any changes to ChAMP do not signal a reversal of the U.S. government's commitment, but rather further strengthen the program." -American Chemistry Council.
"It is extremely disheartening that the administration would abandon its priority-setting chemicals management process before it is even given the opportunity to work." -National Petrochemicals and Refiners Association

"We urge EPA to not delay the forward progress it has been making under ChAMP." - Society of Chemical Manufacturers.

CHAMP for Better or WorseCHAMP represents a largely "voluntary" effort by the chemical industry to provide information on High Production Volume (HPV) chemicals. "Voluntary" in quotations, because such programs have become the preferred way for industry to avoid the burden of regulation by stepping up to the plate first. So the response of industry can be understood in the context of fears that the program which succeeds CHAMP may very well require a bit more -- meaning more cost and more bureaucracy in the pursuit of more protection of American citizens.

The Environmental Defense Fund and others have criticized CHAMP for an insufficient standard of protection, pointing out that the data submitted voluntarily by industry shows large gaps in knowledge about the chemicals currently on the market. Worse, according to EDF, is the process EPA applies to the incomplete data. CHAMP throws chemicals with no evidence of a high hazard into the "don't worry" or "don't worry too much" boxes. EDF argues that in the face of incomplete data, EPA should flag chemicals for priority research whenever the data is incomplete.

As is often the case in the complexity of the real world, both sides are right. The chemicals which have incomplete data are most often the ones that industry knows are not too bad, based on years of handling these chemicals without observing any clusters of illness related to them. So the assumption that these chemicals are "safe" is not groundless in spite of a lack of specific animal studies. Perhaps hiding behind the PETA issues, industry makes a strong case that testing should not be done simply so that check-boxes can be ticked.

What Comes After CHAMP?
But EDF can rightly point out concerns that are not addressed by industry's stance that some chemicals are simply "recognized as safe." Changes are occurring in our bodies and the environment that are not sufficiently explained nor attributed. More study is needed, or we are effectively using ourselves, and our only planet, as a giant laboratory.

And no matter who is right, the key fact is that the US EPA has to do something. Clearly the Obama Administration is committed to environmental protection. So the message behind the suspension of the Bush era CHAMP program can only imply a finding or anticipated finding, perhaps under cost-benefit analysis, that CHAMP is grossly, indefensibly ineffective. Subtext: US citizens have been inadequately protected for years in spite of money being thrown at the problem (EPA requested a hefty increase in its 2010 budget for more hiring in CHAMP).

The anticipated successor to CHAMP is the Lautenberg Kids Safe Chemical Act. This law would update the decades old Toxic Substances Control Act (TSCA). In the wake of European REACH, EPA will be under pressure to expect more, much more, from industry. A battle looms. Will industry be able to maintain its stance that "responsible care" can protect people and the environment most cost-effectively? Or will they face an era of regulatory control championed by a public confused and fearful as they confront daily a chemical soup.
National Association of Chemicals Distributors
June 2009

Modernizing the Toxic Substances Control Act without disturbing the delicate balance between protection of human health and the environment, and sustainment of a vital industry and its customers.

The U.S. Environmental Protection Agency (EPA) regulates chemicals through authority granted by a number of federal statutes, most notably the 1976 Toxic Substances Control Act (TSCA.) Over the years, EPA has used TSCA to review more than 47,000 new chemical submissions and lists 83,000 chemicals on its current TSCA Inventory. Since 2007, EPA has been working to enhance TSCA through the Chemical Assessment and Management Program (ChAMP). ChAMP was created to implement commitments that the United States made at the Security and Prosperity Partnership of North America (SPP) Leaders Summit to complete screening-level chemical prioritizations and initiate action as appropriate on an estimated 6,750 chemicals being produced or imported in high and moderate volume quantities. Despite these efforts, the current legislative climate and action taken by other governments worldwide have driven some in Congress to re-examine the authority and scope of TSCA and potentially expand its power to "better protect the public from chemicals."
Based on weak scientific data, individual states and Congress have taken action to ban certain types of chemicals in the name of consumer safety. In September of 2008, California became the first state to enact a comprehensive chemicals management program. As individual states take action, a major concern is that federal and state programs may be duplicative or conflicting. This could make chemical distribution across state lines extremely difficult. In July 2008, Congress overwhelmingly approved a measure to ban certain types of phthalates from children’s products. This legislation, as well as other legislation being introduced, has called for use of the "precautionary principle," which is the basis for the European Union REACH regulation.
Registration, Evaluation, Authorization and restriction of Chemicals (REACH) is a 2006 European Union (EU) regulation that addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. It took seven years to pass and has been described as the most complex and strictest legislation in EU history and will impact industries throughout the world. When REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the EU in quantities of one ton or more per year to register these substances with a European chemicals agency in Helsinki, Finland. Because REACH applies to some substances that are contained within other products, any company importing goods into Europe could be affected.
Last year, Senator Frank Lautenberg (D-NJ) introduced the Kids-Safe Chemical Act of 2008, S. 3040. Congresswoman Hilda Solis (D-CA,) also introduced the measure for consideration, H.R. 6100. The bill was cosponsored by Henry Waxman (D-CA,) now the Chairman of the House Energy and Commerce Committee with jurisdiction over EPA. The existence of REACH and the chemical ban proposals pending in Congress and the states along with the new Chairmanship for Mr. Waxman have pushed this issue higher on the priority list for the 111th Congress.

While TSCA reform has yet to solidify into real legislative proposals in the current Congress, Senator Lautenberg has indicated that he will reintroduce the Kids Safe Chemicals Act in 2009. This legislation would inject the "precautionary principle" into the chemicals management process and shift the burden of proof away from the government and to the chemical company. Critics say this approach is like altering our judicial system toward the philosophy that a defendant is "guilty until proven innocent."

Meanwhile, on February 26, 2009 the House Subcommittee on Commerce, Trade, and Consumer Protection held the first of what is expected to be a series of hearings on the potential overhaul of TSCA. Committee Members and their witnesses expressed a strong desire to explore the possibility of REACH as an appropriate model for the U.S. while industry witnesses criticized REACH and similar programs, favoring instead a "true risk-based system" to align economic and regulatory regimes. However, even the chemical industry has indicated it is not opposed to updating or modernizing TSCA. American Chemistry Council (ACC) and Society of Chemical Manufacturers and Affiliates (SOCMA) testimony echoed this point but were very clear on the principle that the U.S. should not go the route of Europe and completely change its philosophy regarding chemicals management.


In considering TSCA reform, NACD urges Congress to support approaches like ChAMP, which has the potential to quickly test and provide public information on more chemicals than a REACH type of framework. NACD is concerned with approaches such as REACH which follow the "precautionary principle," create a cumbersome bureaucracy, and stifle innovation. In addition, NACD believes that there should be one uniform federal system for chemicals management rather than a patchwork of 50 different state standards.

NACD members are committed to the distribution of products that can be used safely and without harm to the environment as well as meeting or exceeding governmental safety requirements. Any evaluation of TSCA must recognize that the chemical industry’s innovation has played an integral role in the U.S. economy, and that sweeping revisions could prove highly detrimental to Americans’ way of life with no measurable benefit.

NACD Government Affairs staff will continue to participate in the discussions with industry groups as well as Capitol Hill and Committee staff as this issue continues to develop in the 111th Congress with an eye toward chemicals management policies based on sound scientific data and an adherence to the risk-based approach which has served the public well.
EU chemicals law REACH inspires US bill

Published: Monday 18 July 2005
Senator Frank R. Lautenberg has introduced a bill to regulate chemicals in the US after a government report criticised current legislation for failing to protect Americans from toxic substances.

US Senator Frank R. Lautenberg introduced draft legislation aiming at better protecting children, mothers and workers against potentially hazardous chemicals.
Introduced on 13 July, the 'Child, Worker and Consumer Safe Chemicals Act' is largely inspired by the hotly debated EU proposal for the registration, evaluation, and authorisation of chemicals (REACH) now at final stage of adoption before the European Parliament.
The draft US bill would force chemical manufacturers to provide health and safety information on chemicals used in consumer products like baby bottles and food wrapping instead of presuming a substance is safe until proven dangerous.
The principle, know as the reversal of the burden of proof, is the cornerstone of REACH.
Senator Lautenberg's proposal follows the publication in June of a US federal report detailing the failures of the 1976 Toxic Substances Control Act (TSCA) in protecting Americans from hazardous chemicals.
The report , by the United States Government Accountability Office (GAO), recommended that the US congress consider providing the US Environmental Protection Agency (EPA) with additional authority to assess chemical risks.
According to Lautenberg, procedures under the TSCA are so daunting that, in 29 years, only five toxic substances have been regulated by the EPA. Currently, the EPA has to demonstrate a chemical poses an "unreasonable risk" to restrict or ban it.
"Most Americans believe their government is making sure that chemicals used in the market place are safe. Unfortunately, that simply isn't true," said Senator Lautenberg. "Study after study has shown we have dozens, if not hundreds, of synthetic chemicals in our bodies, yet we have very little information about how they impact our health."

The bill is sponsored by Democrat political heavyweights including 2004 Presidential candidate John Kerry and Hillary Clinton.
In a separate development, the Environmental Working Group (EWG) on 14 July published analyses of the blood from the umbilical cord of ten newborn babies. Performed by an independent laboratory, the tests revealed the presence of 287 industrial chemicals in the blood samples tested, leading the EWG to conclude that "industrial pollution begins in the womb".
However, the correct interpretation of blood tests - a practice know as biomonitoring - and their use in policy-making is still subject to controversy (see related LinksDossier).