Today the U.S. Environmental Protection Agency (EPA) announced that BASF Corporation (BASF) has agreed to pay $5,200 for importing nearly 20,000 lbs of an improperly labeled wood preservative in violation of the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). BASF is a large international chemical company.

“It is important that shipments have the required labels because they have information about the product’s environmental and human toxicity, what to do in case of an accidental exposure and how to safely and effectively use and handle the pesticide,” said Scott Downey, EPA’s Pesticide and Toxics Unit Manager in Seattle.

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Consumers with Allergies Will Benefit From Improved Food Labels

Effective January 1, 2006, the Food and Drug Administration (FDA) is requiring food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods. As a result of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say “contains” followed by name of the source of the food allergen after or adjacent to the list of ingredients.

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The violations resolved in this settlement consist of multiple failures by DuPont to report information about substantial risk of injury to human health or the environment by perfluorooctanoic acid, or PFOA. PFOA is used during the manufacture of fluoropolymers, which are used in common household products such as nonstick cookware.

DuPont will pay $10.25 million — the largest civil administrative penalty EPA has ever obtained under any federal environmental statute — to settle violations alleged by EPA over the company’s failure to comply with federal law. Under the settlement, filed with the Agency’s Environmental Appeals Board, Dupont is also committing to $6.25 million for Supplemental Environmental Projects (SEPs).

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The List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern has been published in the Canada Gazette, Part II. This is a necessary step toward bringing into force the new Pest Control Products Act, which was given Royal Assent in December 2002. Establishing the List is necessary to meet the objectives of the new Pest Control Products Act. The List is designed to increase transparency of the pest management regulatory system, in accordance with the new Pest Control Products Act. The List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern will come into effect at the same time the new Act comes into force.

The List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern and Explanatory Note are available in the Canada Gazette, Part II, Vol. 139, No. 24, page 2641.

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After an extensive, multi-year scientific and technical review, EPA has removed methyl ethyl ketone (MEK) from the Clean Air Act list of toxic air pollutants. Declassifying MEK will not compromise public health and may even pose a public health benefit as companies substitute MEK for more toxic or environmentally damaging chemicals. Although removed from the list of toxic air pollutants, MEK remains regulated as a volatile organic compound.

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The European Commission welcomes the Council’s political agreement on a comprehensive new system aimed at ensuring greater safety in the manufacture and use of chemical substances. The new system, REACH, will establish an integrated system for the registration, evaluation, authorisation and restriction of chemicals. REACH will ensure that the gaps in existing information on the hazardous properties of some 30,000 chemicals are filled and that the necessary information on the safe use of substances is transmitted along the industrial supply chain leading to reduced risks for workers, for consumers, and for the environment. REACH will reverse the burden of proof so that industry, both producers and importers of substances, rather than the public authorities, will have to assume greater responsibility for providing the necessary information and taking effective risk management measures. The formal Common Position of the Council should be approved under the Austrian Presidency in May 2006, a step that will pave the way for the second reading of the proposal by the European Parliament. Parliament adopted its first reading of REACH on 17 November.

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1. Part I of the Non-domestic Substances List (see footnote 1) is amended by deleting the following:
5719-73-3 52320-66-8 126990-35-0
13587-19-4 70983-77-6 145417-44-3
15217-42-2 74499-71-1 216439-38-2
17865-32-6 82168-31-8
38783-61-8 84434-11-7
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2. Part II of the List is amended by deleting the following:
14424-6
Rosin, maleated, polymer with an alkylphenol, formaldehyde, pentaerythritol and polymerized rosin

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The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.

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The U.S. Consumer Product Safety Commission (CPSC) today announced an agreement with the Mexican government aimed at further improving consumer safety and making both the United States and Mexican marketplaces among the safest in the world. This agreement is also part of the “Security and Prosperity Partnership” between the U.S., Mexico, and Canada.

CPSC Chairman Hal Stratton and Carlos Francisco Arce Macías, Federal Attorney for Consumer Protection of the United Mexican States (Profeco), signed the Memorandum of Understanding (MOU) at a ceremony in Bethesda, Md. The agreement calls for both agencies to work toward reducing product-related deaths and injuries in both countries, by exchanging information about product recalls, violations of federal safety laws, and enforcement actions. In addition, CPSC and Profeco will share scientific data, information on emerging hazards, safety research, hazard reduction strategies and notification of changes in product safety laws. The agreement also calls for both agencies to share inspection and laboratory test results, when appropriate.

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As part of the Food and Drug Administration’s continued commitment to improve communication about risks posed by prescription medications, its Center for Drug Evaluation and Research (CDER) is holding a public meeting today to evaluate current practices and to explore new tools and strategic partnerships to enhance future efforts.

“In the past year we have made significant strides in alerting healthcare professionals and their patients of emerging risks associated with prescription medications,” said Andrew von Eschenbach, MD, Acting FDA Commissioner. “We intend to use the public feedback we receive at this meeting to advance our understanding of the effectiveness of our current efforts and to develop new tools to hone our ability to inform the public.”

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