(Washington, D.C. – April 25, 2006) EPA and the 3M Company reached a $1.5 million settlement to resolve reporting violations under the Toxics Substances Control Act (TSCA) that the company voluntarily disclosed to EPA. EPA filed the settlement with the agency’s Environmental Appeals Board today, for their review.

3M voluntarily disclosed all of the violations covered by this settlement under the terms of a TSCA corporate-wide audit agreement. Under the terms of the settlement, 3M neither admitted nor denied that it had violated TSCA and EPA made no substantive determination in all but 10 instances. 3M had previously agreed and subsequently performed a comprehensive management systems review of 28 separate business units and facilities and to determine the compliance status of all TSCA-regulated chemicals and processes. 3M agreed to pay a $1,521,481 penalty for 244 separate counts under TSCA. As a result of the audit, 3M has corrected a number of violations, including failures to notify EPA on new chemicals, late reporting on substantial risk information, and other reporting violations. During the course of the audit, 3M produced valuable, previously unreported information that will help the scientific community to better understand the presence of toxic substances in the environment.

“EPA takes violations of toxic substances laws seriously and is committed to enforcing those laws,” said Granta Y. Nakayama, assistant administrator for EPA’s Office of Enforcement and Compliance Assurance. “We are hopeful that today’s action will serve as a reminder of the importance of timely industry reporting of substantial risk information to EPA.”

Several of the violations concerned reporting on perfluorinated compounds, including perfluorooctyl sulfonates (PFOS) and perfluorooctanoic acid (PFOA). PFOS-related compounds were the active ingredients used for decades in the original formulation of 3M’s Scotchgard stain and water repellents. 3M voluntarily stopped manufacturing PFOS in the United States in 2000, and phased out all of these chemistries on a global basis by the end of 2002. Data submitted by 3M and others led EPA to begin an investigation of these compounds in 2000.

EPA followed up the phase out of PFOS by taking action to implement significant new use rules to restrict the return of PFOS-related chemicals to the U.S. market.

Source

An article in the San Luis Obispo Tribune discusses “bounty hunters” who find companies who are not complying with Prop 65 regulations and keep a share of the fines:

Seven local wineries have been targeted by a Bay Area resident for allegedly failing to notify the public that cancer-causing chemicals are used in the artwork on the outside of some wine glasses.

The wineries are among hundreds of businesses statewide that Russell Brimer has targeted and among the dozen county businesses that have received similar notices of violations in the last six months, often filed by so-called bounty-hunters who collect penalties for the government and keep a cut of the money.

There are not similar programs in Canada, but a disgruntled former employee or competitor could cost a company a great deal of money by reporting consumer labels which are not compliant with CCCR-2001, for example. Having a regulatory compliance expert examine your company’s labels can prevent this kind of thing from happening.

Source: San Luis Obispo Tribune.

An article on ConsumerAffairs discusses a $1 million settlement by Pepsico for a Prop 65 violation:

Pepsi has agreed to eliminate leaded labels on bottled soft drinks imported from Mexico to resolve California’s allegations that Pepsi violated the state’s Proposition 65 by failing to warn consumers the bottles’ labels contained lead, a toxic substance that can cause birth defects, learning disabilities and cancer.

Prop. 65 and other state food safety laws would be pre-empted by a bill recently passed by the U.S. House and currently awaiting a vote in the Senate — H.R. 4167, “The National Uniformity for Food Act of 2005.” If the federal legislation had been law, Pepsi could have continued to sell Mexican sodas in bottles with leaded labels until the federal government took action.

“This settlement is a classic example of why California’s Proposition 65 is a law that works,” said state Attorney General Bill Lockyer. “Not only does the law require manufacturers to warn the public about the risk of exposure to harmful chemicals, it gives companies incentive to make their products safer. I congratulate Pepsi for meeting that challenge, taking the path of responsible corporate conduct and helping reduce Californians’ exposure to this extremely dangerous substance.”

Regulatory Compliance companies such as Nexreg Compliance can assist your company in meeting their Prop 65 requirements, which can save your company a great deal of headaches from cases like this.

Source: ConsumerAffairs.com.

An article on News-Medical.net reminds us of changes made to U.S. food labelling laws:

If you or someone in your family suffers from a food allergy, you know how difficult it can be to decipher the food label if the product contains an offending substance.

Now, thanks to a food labeling law that went into effect this January, food manufacturers must disclose in plain language whether products contain any of the top eight food allergens.

While more than 160 foods have been identified as sources of allergic reactions, 90 percent of the allergic reactions associated with foods are caused by one of eight foods: milk, eggs, fish, crustacean shellfish, peanuts, tree nuts, wheat and soy.

Manufacturers have two options for declaring the presence of these food substances in foods. One is to add a “contains” statement next to the ingredient list that identifies the types of allergenic foods contained in the product; for example, “contains milk and wheat.” The other option is to place the food source in parentheses next to ingredients derived from one of the eight potential offending foods classes, such as sodium caseinate (milk), albumin (egg).

The article is a decent primer on the subject, so if you’re interested in the subject, I suggest you check out News-Medical.net.

(Seattle, WA, – April 19, 2006) Today the U.S. Environmental Protection Agency (EPA) settled claims for nearly $64,000 with three companies charged with importing and selling improperly labeled pesticides.

EPA settled its claims with Arch Chemicals, Inc., Janssen Pharmaceutical, Inc. and JR Simplot for violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

“For the safety of our citizens, all imported pesticides intended for use in the United States must be registered as required by Section 3 of FIFRA before being permitted entry into the U.S,” said Chad Schulze, EPA’s Region 10 FIFRA Enforcement Officer in Seattle. “Imported pesticides must be properly labeled to ensure that when used as directed, the product does not pose an unreasonable risk to human health and the environment.”

According to EPA officials:

Arch Chemical, Inc., of Smyrna, Georgia, imported improperly labeled pesticides into the U.S. through Seattle, Washington and Los Angeles, California, on 13 separate occasions between June 2005 and January 2006. EPA issued a Stop Sale, Use, or Removal Order for these illegal shipments in July of 2005. Arch has agreed to pay a $52,000 penalty to settle EPA’s claims.

In October 2005 EPA found that Janssen Pharmaceutical, Inc., of Titusville, New Jersey, also imported an improperly labeled pesticide into the U.S. through Seattle, Washington, in violation of FIFRA. At that time, EPA issued a Stop Sale, Use, or Removal Order for the illegally imported pesticide. Janssen has agreed to pay a $4,680 penalty to settle EPA’s claims.

JR Simplot of Boise, Idaho, has agreed to pay a $7,280 penalty to settle EPA’s claims that they violated the federal pesticide law by including substantially smaller percentages of active ingredients in two lawn products than what was stated on their labels. EPA’s allegations are based on a March 20, 2003 inspection of a Simplot facility in St. Louis, Missouri and subsequent analysis of collected samples.

Source

This information is likely old hat to those in the food industry, but a recent article on MSNBC discusses the labeling and testing of water:

Bottled water is highly regulated as a packaged food product by the U.S. Food and Drug Administration (FDA) and subject to FDA’s extensive food safety, labeling and inspection requirements. By law, the FDA Standard of Quality for bottled water requires that regulations for bottled water are at least as stringent and protective of public health, according to the International Bottled Water Organization.

Municipal water is regulated by the Environmental Protection Agency, with frequent testing performed by the agency and local authorities. American Waterworks Director Jack Hoffbauer says that “over 90 percent of the water utilities in this country comply with the EPA regulations and there’s no tougher regulations in the world.”

The full article is available at: MSNBC.com.

FDA Statement Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Contact Lens Solution

FDA is continuing to work closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The agency supports Bausch & Lomb’s decision to voluntarily withdraw ReNu MoistureLoc® contact lens solution from the market until the agencies have had a chance to conclude their investigation.

FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22, 2006, and will continue inspections of the Greenville, SC manufacturing plant and other facilities through next week. While the investigation continues, FDA will work with CDC to identify and confirm cases of Fusarium keratitis reported by state health departments and from FDA Medwatch reports.

FDA and CDC are advising consumers to take precautions to reduce their risk for Fusarium keratitis through preventive practices for contact lens wearers that include:

• Wash hands with soap and water, and dry (lint-free method) before handling lenses.
• Wear and replace lenses according to the schedule prescribed by the doctor.
• Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
• Keep the contact lens case clean and replace every 3-6 months.
• Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.

For more information, please visit FDA’s Contact Lens and Eye Infections page at: http://www.fda.gov/oc/opacom/hottopics/contacts.html

Source

FDA is committed to ensuring the safety of food and beverages consumed by Americans and providing timely and factual information when safety questions are raised. We are issuing this statement today to better describe the steps FDA is taking in response to reports that benzene has been found in some soft drinks.

Benzene, a carcinogen, is found in the environment from natural and man-made sources. In November 2005, FDA received reports that benzene had been detected at low levels in some soft drinks containing benzoate salts (an antimicrobial agent) and ascorbic acid (Vitamin C), particularly under certain conditions of storage, shelf life and handling.

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) initiated a survey of benzene levels in soft drinks following receipt of the November 2005 reports. This survey indicates that the vast majority of beverages sampled (including those containing both benzoate salts and ascorbic acid) contain either no detectable benzene levels or are well below the 5 parts per billion (ppb) U.S. water standard. The results of this survey, which will be released in the near future, indicate that the levels of benzene in these beverages do not pose a safety concern.

Source

Bloomberg has a terrific article on the biotech industry and GMO crops. This section, in particular, should be of interest to some of Nexreg‘s readers and clients:

The EU introduced stricter gene-modified food laws, including new rules on labeling, and created a food agency to screen biotech applications before ending its ban two years ago.

National governments can still slow or block approvals because the commission must consult national authorities when it plans to give permission for the EU-wide sale of gene-modified products for food, animal feed or cultivation.

The 10 approvals since the EU moratorium ended all resulted from the commission acting on its own after member states failed to muster a sufficient majority for or against, a stalemate that drags decisions out for months.

The World Trade Organization ruled in February that the EU moratorium was illegal and left unanswered the question of whether the current pace of approvals is compatible with global- trade rules. The WTO ruling resulted from a complaint by the U.S., Argentina and Canada, the world’s three biggest growers of gene-modified seeds.

See the full article at Bloomberg.com.

An article on Marketwatch discusses how much Merck believes putting a warning label on Vioxx would cost their company in sales:

Another figure thrown out by Lanier was $229 million. That’s the amount of Vioxx sales that an internal Merck analysis once found the company would lose if it had to put a stricter heart-warning label on Vioxx earlier than expected. Vioxx sales were about $2.5 billion in 2003, the last full year the drug was on the market.

The $229 million figure also happens to be the amount that a Texas state jury awarded last year in punitive damages to the widow of a man who had a fatal heart attack after using Vioxx – the only other Vioxx case in which punitive damages were awarded. That amount is expected to be reduced under Texas law.

Merck’s Jones also told jurors that Merck’s profits from Vioxx sales in New Jersey were about $56 million. She said that’s a lot of money but jurors should “put it into perspective,” noting that jurors already had awarded about 8% of that to McDarby and his wife last week.

See the full article at: MarketWatch.com