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Conrad Jr. J.W.,Conrad Law and Policy Counsel | Becker R.A.,American Chemistry Council
Environmental Health Perspectives | Year: 2011

Objectives: We examined the extent to which consensus exists on the criteria that should be used for assessing the credibility of a scientific work, regardless of its funding source, and explored how these criteria might be implemented. Data sources: Three publications, all presented at a session of the 2009 annual meeting of the Society for Risk Analysis, have proposed a range of criteria for evaluating the credibility of scientific studies. At least two other similar sets of criteria have recently been proposed elsewhere. Data extraction/synthesis: In this article we review these criteria, highlight the commonalities among them, and integrate them into a list of 10 criteria. We also discuss issues inherent in any attempt to implement the criteria systematically. Conclusions: Recommendations by many scientists and policy experts converge on a finite list of criteria for assessing the credibility of a scientific study without regard to funding source. These criteria should be formalized through a consensus process or a governmental initiative that includes discussion and pilot application of a system for reproducibly implementing them. Formal establishment of such a system should enable the debate regarding chemical studies to move beyond funding issues and focus on scientific merit.

Swift T.K.,American Chemistry Council
Chemical Engineering Progress | Year: 2012

The global economy, which entered the third year of recover in June 2011, has reached a critical state, and the US chemical exports , favored due to overseas growth, a weak dollar, and a favorable oil-to-gas price ratio, has shown some positive signs. The consensus is that US chemical output will improve during 2012 and continue to improve further in 2013. China and other emerging markets in Asia-Pacific and Africa, and the Middle East, will experience noteworthy gains, and by 2016, capital spending by global chemistry will exceed $800 billion. The factors influencing capital spending include business cycle, which saw a recovery in 2012 and 2011, and interest rates, which are low and make for a low cost of capital. By mid-decade, capital spending by the American chemistry business will accelerate, reaching $45 billion in 2016.

U.S. lawmakers have agreed on landmark bipartisan legislation to modernize the Toxic Substances Control Act (TSCA), a 40-year-old law that governs chemicals used in household items and industrial products. After years of negotiations, the House of Representatives passed the legislation (H.R. 2576) on May 24 by a vote of 403-12. The Senate is expected to follow suit in early June, sending the measure to the President, who is likely to sign it. The White House says the bill meets the Obama Administration’s principles for reforming TSCA. In a major change from current law, the legislation will make it easier for the Environmental Protection Agency to request safety data from chemical manufacturers on new and existing substances that may pose a risk to human health or the environment. Currently, EPA must demonstrate that a chemical poses a risk before it can seek such information through a regulation. The legislation will allow EPA to collect fees from industry to pay for federal chemical safety evaluations. It also will require the agency to review all confidential business information claims regularly attached to chemical information that industry submits to EPA. Such claims often hide the identity of chemicals from public view. One of the most contentious parts of the bill is a provision that allows EPA action to override state actions. In the absence of federal rules, some states have regulated toxic chemicals. The legislation allows state actions taken before April 22, 2016, to stand. A handful of Democrats in the House and many environmental and public health groups oppose the bill primarily because of the state preemption provision. The bill “improves current law in many ways and, depending on implementation by EPA, should do some good,” says Andy Igrejas, national campaign director for the advocacy group Safer Chemicals, Healthy Families. “Unfortunately, it still goes backward in a few important ways that reflect the enormous lobbying and political strength of the chemical industry,” Igrejas says. In particular, it curbs state authority and weakens EPA’s authority to intercept imported products that contain toxic chemicals, he says. Earlier this month, Sen. Barbara Boxer (D-Cal­if.), a key congressional player in TSCA reform, announced her support for the bill after fighting for many years for the rights of states. “Under our agreement, the states are free to act on any chemical until EPA takes a series of steps to regulate a specific chemical,” she said. The chemical industry strongly supports the bill, saying the changes will rebuild public confidence in the safety of chemicals in commerce. Cal Dooley, chief executive officer of the American Chemistry Council, which represents much of the U.S. chemical industry, says the legislation is “a true compromise that balances the interests of multiple stakeholders.”

This story has been updated. The Senate has passed a much-anticipated bill proposing broad reforms to an existing chemical safety law — one which environmentalists have long argued puts the American public at unnecessary risk of exposure to toxic substances. The bill, dubbed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, has been in negotiations for more than two years and finally went to a vote Thursday night, where it passed with bipartisan support. It proposes a major overhaul of the 1976 Toxic Substances Control Act (TSCA), which gives the Environmental Protection Agency authority to regulate chemicals in the U.S. In recent years, however, environmentalists have called for major changes to the existing law, which they’ve argued does not give the EPA enough power when it comes to restricting toxic substances. “This law is about 40 years old, and it simply hasn’t kept up with the new science that is showing how chemicals can affect our health,” said Richard Denison, lead senior scientist with the Environmental Defense Fund. A major problem with the existing TSCA, according to Denison, is that it requires the EPA to demonstrate such a high burden of proof that a chemical is dangerous to human health as to make it nearly impossible to restrict a substance’s use. The “poster child” for this issue is the EPA’s failed attempts to ban asbestos — a substance known for its cancer-causing qualities — in the 1980s. As a result of restrictions in the current law, Denison said, the EPA has not been able to generate adequate information on many chemicals still commonly used in the U.S., and there are also many restrictions on the information it’s permitted to share with the public, so as not to divulge confidential trade information. “Most people assume that the chemicals in the products and materials they encounter every day have been thoroughly tested and shown to be safe,” Denison said. “In fact, only a handful of chemicals have ever been reviewed for safety.” The new bill would grant greater authority to the EPA to study the effects of chemicals and regulate their use and has received wide support from both Democrats and Republicans. The bipartisan support is a reflection of the amount of time senators have spent negotiating the bill, a process that has required “careful balancing of the interests on both sides in this debate,” Denison said. While the bill grants much greater regulatory authority to the EPA, which supporters hope will lead to more uniform, national health-based standards, it also includes some protections for the industry from state regulations. The bill has also received support from members of the chemical industry. Cal Dooley, CEO of the American Chemistry Council — a trade association representing chemical manufacturers — issued a statement Thursday calling the new bill “a watershed moment in the history of U.S. environmental legislation.” And the president of the National Association of Chemical Distributors, Eric Byer, also issued a statement Thursday saying, “Today’s vote puts us on the doorstep of finally reforming an outdated law in a way that will build confidence in the U.S. chemical regulatory system, protect human health and the environment from significant risks, and meet the commercial and competitive interests of the U.S. chemical industry and the national economy.” However, the bill has its critics in the environmental world. Representatives of a coalition of more than 450 organizations and businesses, known as Safer Chemicals, Healthy Families, have pointed out what they consider to be key flaws in the bill. For instance, while the bill gives the EPA greater power to review and regulate chemicals, it includes a prioritization system — which essentially classifies chemicals as “high priority” or “low priority” for further investigation — that some have argued might allow certain dangerous chemicals to slip through the cracks, said Andy Igrejas, national director of Safer Chemicals, Healthy Families. Additionally, the coalition’s communications director, Tony Iallonardo, suggested that the bill could make it harder for the EPA to intercept imported products inappropriately containing toxic chemicals. And the coalition also opposes the aspects of the bill that would weaken states’ abilities to independently regulate chemicals while they’re undergoing review by the EPA. As the bill has only passed in the Senate for now, it will need to be subjected to a vote in both chambers before being enacted into law. For its part, the House of Representatives passed a similar, although much more limited, bill earlier in 2015 proposing some smaller-scale reforms to the TSCA. “The House and Senate bills have to be reconciled in order to get a bill done and to the president and signed,” Denison said. “We hope it ends up with the kind of comprehensive reform that the Senate bill outlines in order to really overhaul the law.” But while Safer Chemicals, Healthy Families doesn’t endorse either bill at the moment, Iallonardo and Igrejas noted that the House bill doesn’t contain some of the provisions they oppose in the Senate bill. And since the House bill also passed with bipartisan support, they’ve argued that it’s possible to remove some of these provisions in future negotiations without losing the support necessary to pass a final bill in both chambers. At the same time, there are aspects of the Senate bill — such as an increase in dedicated funding to the EPA’s chemical reviews — that the coalition supports. When it comes time to reconcile the two bills, Igrejas said, “We’re urging Congress to really focus on just the basics of making this law work, empowering EPA to identify and restrict where necessary the chemicals that causing a problem and really having the authority to sling through and make those restrictions stick and be meaningful for the public.” Such negotiations between the House and the Senate could be complete, and a final bill sent to a vote, by early 2016. And while disagreement continues over which provisions should remain in the final product, most have agreed that the moves toward reform are a much-needed step in fixing a badly outdated, and even detrimental, law. “For the first time ever, we have both parties in both houses of Congress recognizing the need for reform and committed to getting it done,” Denison said. “Hopefully it will provide Americans the protection they need from exposure to toxic chemicals.” The world just adopted a tough new climate goal. Here’s how hard it will be to meet Obama just released the biggest energy efficiency rule in U.S. history Why the Paris agreement could be the beginning of the end for global warming denial For more, you can sign up for our weekly newsletter here, and follow us on Twitter here.

News Article
Site: www.nature.com

Around the world, safety regulations are being revised as new information about the health and environmental effects of chemicals becomes available. In June, US President Barack Obama signed the first bill to reform the Toxic Substances Control Act since its enactment 30 years ago. The revised act mandates greater public transparency and the timely assessment of existing chemicals by the US Environmental Protection Agency (EPA). Elsewhere, the European Union's REACH (registration, evaluation, authorization and restriction of chemicals) legislation and similar laws are also evolving. Improved regulation is necessary to protect people and the environment from harmful substances. But it does little for inventors who face the perplexing task of creating safer chemicals and products1. In the current system, safety information is gathered after a chemical is invented, or in many cases, after it is incorporated into products and distributed to the public. The molecular interactions of chemicals within products are unaccounted for, meaning that ingredients lists may be misleading as sources for product safety information. Such factors make it nearly impossible for an inventor to avoid the risk of creating an unsafe chemical or product. The evaluation and communication of chemical and product safety needs to change. Three approaches are proposed here to start a conversation between scientists, business representatives and policymakers about our future public and environmental health. Standardize chemical-safety tests. Controversy on chemical safety often arises when organizations, from corporations to research centres and government agencies, test the same compound using different methods. One technique may suggest that a compound is hazardous, another that it is benign. For example, glyphosate, a widely used herbicide, was in 2015 deemed a “probable human carcinogen” by the International Agency for Research on Cancer2. Many other regulatory agencies, including the European Food Safety Authority, conversely concluded that the herbicide was “unlikely to be carcinogenic”. The discrepancy lies in the different studies taken as evidence, which leaves the public more confused about the safety of glyphosate than before. Standardized tests reduce the use of replacement chemicals that are as problematic as, or worse than, the original substance. For example, some structural analogues of bisphenol A (BPA), which are used in a variety of plastic products, have similar toxicity and hormonal effects to BPA3. Likewise, hydrofluorocarbons and hydrochlorofluorocarbons are often used as substitutes for chlorofluorocarbons (CFCs), ozone-depleting chemicals that were used widely as refrigerants and aerosol propellants. Although not as harmful as CFCs, the substitutes still damage Earth's ozone layer4. Further, by knowing which tests must be carried out in advance, inventors will save time and money, making it easier to rationalize the large investment necessary to develop a material. Creating a set of nationally or internationally standardized safety tests will require input and compromise from industrial, academic and governmental organizations, such as the American Chemistry Council, the Environmental Working Group and the EPA. Everyone will endorse some tests, such as those for physical chemical properties. Others will be difficult to agree on or are yet to be established, such as those for endocrine disruptors, a type of hormone-mimicking molecule5. Information gaps will need to be identified, such as methodologies for testing the various phases of materials. A mechanism to periodically review and amend the list of tests should be put in place, based on existing processes for evaluating individual molecules used by the EPA, REACH, corporations and government bodies. Test finished products. Ingredients entering a manufacturing process do not necessarily represent the chemical composition of the final product. Some molecules disappear; others interact to form new compounds when exposed to different substances or changes in temperature and pressure. A better way to understand a product's impact on human health and the environment is to test the final product. For example, one study that screened a sample of pizza box6 revealed many unidentifiable compounds, raising questions about the content and safety of everyday products. A product could be graded on a scale of 1 to 10 (1 being benign and 10 being highly toxic) based on its performance in a series of standard tests in different categories. Consumers would be informed of product safety and suppliers need not reveal trade secrets. If a product's performance in one or more of the tests is unacceptable, the manufacturer can look down its supply chain, identify which material is problematic, and make modifications. Make test results public. The quantitative results of chemical and product tests should be disclosed and presented in an unbiased way. Organizations, including government agencies, non-governmental organizations and trade associations should create policies and processes to interpret the data. For example, a product might be scored for carcinogenicity, emissions and endocrine-disrupting potential. If all products in a commercial category provide this information, a consumer can make an informed decision by comparing the numbers. Consumer or non-governmental organizations should prepare guidelines on what scores one should look for. It is important to ensure consumers know that no product is without risk. Producers with 'unacceptable' product scores would have to explain to the public why they feel that the exposure of humans and the environment to a substance is justified. Government agencies and other groups can ban products or product categories that score poorly. The first step towards better chemical safety is to create a list of desired endpoints — the information we would like to know about a product, such as liver toxicity, ozone depletion or carcinogenicity. There shouldn't be so many goals that the task of achieving them is impossible, or so few that it is meaningless. Step two is to identify specific tests for each endpoint. Where consensus cannot be achieved, a mechanism for reaching agreement must be developed. Third, we must develop protocols to define sample preparation and methods of analysis. The main goal is to create criteria that can be used to audit laboratories that perform the assays. Different states of matter and various product types should be anticipated. Finally, scientists should convene regularly to evaluate the current state of the art and science, and make decisions based on new knowledge that challenges existing tests or offers improvements. For example, this year marks the twentieth anniversary of the first Green Chemistry Gordon conference; such meetings would be good forums for discussing commercial successes and remaining challenges in sustainable chemistry. Overhauling chemical regulation is a daunting task, but we need a better way of protecting human health and the environment.

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