New Study Finds PFOA Levels in Drinking Water Are Safe

BETHESDA, MD - The Sapphire Group today released the results of a new study which found that levels of perfluorooctanoic acid (PFOA) found in drinking water supplies are safe for human exposure. PFOA, sometimes referred to as C8, is a substance used in the manufacture of a variety of non-stick and stain
resistant protective coatings.

Concentrations of PFOA found in drinking water supplies range from less than the detectable limit of 7.5 parts per trillion to 3.5 parts per billion near some manufacturing facilities. Studies of workers exposed to high concentrations of PFOA in manufacturing facilities have found no increase in the incidence of adverse health effects.

The Sapphire Group's examination of 239 peer reviewed human and animal studies found a safe level of lifetime exposure to PFOA in drinking water to be up to 6.5 parts per billion. One part per billion is the equivalent of one drop dissolved in 14,000 gallons of water. One part per trillion is the equivalent of a half
drop dissolved in a 660 thousand gallon Olympic swimming pool.

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The Sapphire Group Addresses Recent Chinese Import Concerns
Recent headlines concerning contaminated imports from China have raised many questions as to the safety of foods and other products imported from overseas manufacturers. Fortunately, The Sapphire Group offers a comprehensive suite of toxicity, exposure, and risk assessment services for a wide range of consumer products including foods, personal care products, cosmetics.

If, for example, a product contains either a contaminant or unintended byproduct, those compounds may present a health risk and should be assessed accordingly. Whether the contamination was the result of an isolated incident or an faulty manufacturing process, the responsibility of assuring consumer health still stands with the parent company. In the case of newly developed or reformulated products, consumer safety must also be determined for each compound or chemical involved in the manufacture of the product.

The Sapphire Group is prepared to create a toxicological and/or exposure assessment tailored to fit the specific individual needs of the client to provide them with the most scientifically sound results available. In many cases, a toxicological assessment will involve an in-depth review of available scientific literature, chemical analysis of the product, and exposure scenario assessment. The Sapphire Group’s team is highly experienced in developing risk, toxicological, and exposure assessments for a wide range of compounds (i.e., pesticides, metals, food additives, solvents). In addition to providing expertise in helping companies and organizations comply with United States consumer product regulations, including California’s Proposition 65, The Sapphire Group is well prepared to assist with any international regulations, including the newly activated European Union REACH program.

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The Sapphire Group Addresses the SAB’s Review of USEPA’s Draft Risk Assessment of PFOA and its Salts
The Science Advisory Board (SAB) has completed its review of the US Environmental Protection Agency’s (USEPA) draft Risk Assessment of Perfluorooctanoic Acid (PFOA and its salts. USEPA has proposed that there is sufficient weight of evidence to establish that the mode of action for liver tumor induction in rats following exposure to PFOA is peroxisome proliferator-activated receptor α (PPARα) agonism.

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The Sapphire Group Addresses World Wildlife Fund’s Persistent Organic Pollutant List
In anticipation of the first Conference of the Stockholm Convention on Persistent Organic Pollutants (POPs), the World Wildlife Fund (WWF) has released a list of 20 chemicals for inclusion in the treaty. The 20 additional chemicals proposed by WWF include seven pesticides, five brominated flame-retardants, two perfluorinated compounds, four other chlorinated chemicals or groups, and two unintentionally produced chemicals.

Scientists with The Sapphire Group have considerable experience and expertise in addressing the risks to human health and the environment from these and many other proposed POPs.

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The Sapphire Group Addresses R.E.A.C.H.
REACH, the Registration, Evaluation and Authorization of Chemicals, is a single, integrated legislative system to address chemical hazards as promulgated by the European Union (EU). REACH will require all companies that produce and import chemicals to assess the risks arising from their use and to take the necessary measures to manage any risk they identify. Although many of the regulation’s decision criteria (i.e., high risk chemicals, exposure assessment requirements, adequate control technologies) have not yet been fully defined, it is clear that this regulation will reverse the burden of proof from public authorities to industry for ensuring the safety of chemicals on the market.

Support for the development, enhancement and defense of our clients' products is a critical focus at The Sapphire Group. We offer cost effective solutions to our clients’ product challenges. Our depth of expertise with chemicals and their downstream counterparts allows for our clients to address the new REACH requirements, described below, in a comprehensive, cost-effective manner.

If you are interested in further information about REACH, please contact us.

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View Point: Dr. Robert Tardiff Comments On Cancer and Children
VIEW POINT: The Sapphire Group Offers Insight on Assessing Cancer Risks in Children
One of today’s emerging areas in health science risk assessment is assessing cancer risks in children. Dr. Tardiff, president and CEO and lead scientist for The Sapphire group offers his view point on this new area of study and provides insight as to its potential impact to the makers of commercial and consumer products.

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Dr. Robert Tardiff Serves on Department of Defense Committee to Examine the Risks Associated with Non-Lethal Weapons
Military and law enforcement officials are confronted with variety of circumstances and many that require the use of lethal force. However, with the advancement of material science and weaponry, military and law enforcement officials have an assortment of weapons that act as deterrents without being lethal. The use of non-lethal weapons in crowd control situations, civil disobedience, and military peacekeeping operations provides an adequate response to minimize the dangers while producing limited casualties without death.

Dr. Robert Tardiff is currently serving on a committee sponsored by the Department of Defense (DoD) to characterize the risks associated with the physical injury associated with the use of non-lethal weaponry when used properly. The committee is charged with examining such issues as, "What is the probability of a person sustaining an injury to the eye that might be permanently disabling as opposed to the objective of inflicting pain as a deterrent of hostile behavior?"

By providing the DoD with such estimates of risk, weapons' designers are enabled to optimize the weapons intended use while reducing the unintended consequences. This work represents a unique application of risk assessment approaches and called for the development of novel techniques to identify the health risks with increasing levels of confidence. The committee's efforts include helping the commanding officers understand the appropriate situations in which to use non-lethal weapons, the proper discharge of these weapons and the dangers of inappropriate discharge.

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FQPA Requires Examination of Cumulative Effects of Pesticides
Under the Food Quality Protection Act, Congress mandated the evaluation of the safe levels of exposure to pesticides with an examination of that risk across all types of foods/exposures: "The law requires EPA to consider the validity, completeness and reliability of available study data; the nature of potential toxic effects and available information on the relationship of study results to human risk; dietary consumption patterns and variations in the sensitivities of major identifiable subpopulations; cumulative and aggregate (dietary and nondietary) effects of exposure to the pesticide and other substances with common mechanisms of toxicity; effects on the endocrine system; and scientifically recognized safety factors."

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European Union Strategy for Future Chemical Policy
A proposal from the European Union (EU) Commission, in 2001, outlines a new standard for the data required to approve new and existing chemicals in the EU marketplace. The "overriding goal" is that of "sustainable development."

The white paper outlines the Commission's proposal and clearly expresses their concern regarding the risk posed to our most vulnerable members of society, such as children. The paper states "EU chemical policy must ensure a high level of protection of human health and the environment as enshrined in the Treaty both for the present generation and future generations while also ensuring the efficient function of the internal market and the competitiveness of the chemical industry. Fundamental to achieving these objectives is the Precautionary Principle."

The scope of the policy is to regulate the testing and determine risk reduction measures covering some 2,700 news substances (those placed in the market after September 1981) and existing substances (those with volumes above one tonne), of which there are 30,000. Of these, 140 have been identified as priority substances and are subject to comprehensive risk assessment.

In an effort "to make producers assume responsibility for their products, the Commission has announced its intention to propose Community legislation in this field." To achieve the goal of sustainable development, a number of objectives were identified.

• Protection of human health and the environment
• Maintenance and enhancement of the competitiveness of the EU chemical industry
• Prevention of fragmentation of the internal market
• Increased transparency (Consumers need to be able to make informed decisions and enterprises need to understand the regulatory process)
• Integration with international efforts
• Promotion of non-animal testing
• Conformity with EU international obligations under the WTO

The impact this will have and how it will be implemented will be closely watched by The Sapphire Group to adequately prepare their clients. The testing for existing chemicals under this new proposal may surpass that of the High Production Volume Chemicals. However, if the toxicity data base for a chemical should meets these proposed standards, then it may automatically meet the US standards. Such harmonization may provide substantial benefits to the industries that manufacture and depend on chemicals.

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Amino Acids Identified in the Formation of Acrylamide
Last month, the Canadian government announced that its chemists discovered that at least one amino acid is essential in the formation of acrylamide in cooked foods. Previously, it had been thought it was due to starch but these recent findings show that it is from heating at high temperatures amino acids, the natural building block of proteins. At the moment, it is not possible to say whether acrylamide in such foods is either safe or dangerous. No one has yet demonstrated the bioavailability of acrylamide and/or the bodies natural ability to "detoxify" the chemical; however, The Sapphire Group has been developing approaches to address these matters.

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Acrylamide Found in European Snack Foods and Other Baked Products! What Relationship to U.S. Cooked Foods?
As professionals in the field of health science and experts in the area of foods containing chemicals, The Sapphire Group has been actively engaged in the acrylamide issue since it was reported recently in Europe. For more information on this topic, click the link below.

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Cumulative Risk
Understanding the extent to which risks may be cumulative as individuals confront the same substance under numerous circumstances throughout their life.

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The Sapphire Group Addresses Bioterrorism
RISK ASSESSMENT OF BIOLOGICAL AND CHEMICAL THREAT Understanding and Managing Vulnerabilities and Potential Health Impacts.