Friday, May 28, 2010

CPSC Issues Final Mandatory Rule on Infant Baby Walkers

The U.S. Consumer Product Safety Commission (CPSC) voted (5-0) to issue a final mandatory rule under section 104(b) of the Consumer Product Safety Improvement Act (CPSIA) for infant walkers.

The rule adopts the applicable voluntary industry standard, ASTM F 977-07, Standard Consumer Safety Specification for Infant Walkers, and adds the following more stringent requirements:

using the actual weight of a walker in a calculation to determine the launching distance for the stair fall test,
specifying equipment used in the stair fall test,
adding a parking brake test for walkers equipped with parking brakes.
These changes were made to strengthen the standard and reduce the risk of injury from these products. There has been an 88% reduction in injuries from 1994 to 2008, which may be attributed to the addition of a stair fall requirement included in the 1997 version of the ASTM voluntary standard.

The final infant walker rule would take effect six months after publication in the Federal Register. This is the effective date that was proposed in the Notice of Proposed Rulemaking (NPR). Consistent with the proposed rules recently published for toddler beds and bassinets, the effective date would apply to products manufactured or imported on or after that date.

Section 104 of the CPSIA, Standards and Consumer Registration of Durable Nursery Products, requires the CPSC to study and develop safety standards for certain infant and toddler products, including infant walkers.

Thursday, May 27, 2010

CPSC Approves New Federal Safety Standard for Infant Bath Seats

The U.S. Consumer Product Safety Commission (CPSC) has approved a new federal safety standard for infant bath seats. The vote on the final rule was 5-0.

The federal standard for infant bath seats is the first mandatory standard issued by CPSC as required under the Consumer Product Safety Improvement Act (CPSIA) for a range of infant and toddler durable products.

The new federal requirements for infant bath seats enhance the current ASTM voluntary standard by adding stricter stability requirements to prevent the bath seat from tipping over, tighter leg opening requirements to prevent children from slipping through the leg openings and a larger permanent warning label alerting parents and caregivers that bath seats are not safety devices and that infants should never be left unattended in a bath seat. The federal standard incorporates current voluntary standard provisions requiring latching and locking mechanisms, and compliance with CPSC’s standards for sharp points and edges, small parts, and lead in paint.

Infant bath seats are used in a sink or tub to provide back and front support to a seated infant while he or she is being bathed. They are marketed for use with infants between five and 10 months of age.

From 1983 through November 2009, there were 174 reported deaths involving bath seats and 300 reported non fatal bath seat incidents. Many of the deaths and incidents involve babies left unattended while bathing.

Young children can drown quickly, even in small amounts of water. Never leave a child alone, even for a moment, near any water. Always keep a young child within arm's reach in a bathtub. And never leave a baby or toddler in a bathtub under the care of another young child.

Information gathered by CPSC staff indicates that no baby bath seat currently on the market complies with the new mandatory standard.

The final rule on infant bath seats goes into effect six months after publication in the Federal Register. Bath seats manufactured or imported on or after that date will be required to meet the new mandatory standard.

CPSC staff is working to develop federal standards for nearly 20 other durable juvenile products, including bassinets, cribs, and infant walkers.

CPSC Identifies Manufacturers of Problem Drywall Made in China

The U.S. Consumer Product Safety Commission (CPSC) is releasing today the names of the drywall manufacturers whose drywall emitted high levels of hydrogen sulfide in testing conducted for the agency by Lawrence Berkeley National Laboratory (LBNL). There is a strong association between hydrogen sulfide and metal corrosion.

Of the samples tested, the top ten reactive sulfur-emitting drywall samples were all produced in China. Some of the Chinese drywall had emission rates of hydrogen sulfide 100 times greater than non-Chinese drywall samples.

"Homeowners who have problem drywall in their homes are suffering greatly", said CPSC Chairman Inez Tenenbaum. "I appeal to these Chinese drywall companies to carefully examine their responsibilities to U.S. families who have been harmed and do what is fair and just".

At the U.S.-China Strategic and Economic Dialogue meetings in Beijing May 24-25, U.S. officials pressed the Chinese government to facilitate a meeting between CPSC and the Chinese drywall companies whose products were used in U.S. homes, and which exhibit the emissions identified during the testing procedures. The Strategic and Economic Dialogue represents the highest-level bilateral forum to discuss a broad range of issues between the two nations.

The following list identifies the top 10 drywall samples tested that had the highest emissions of hydrogen sulfide, along with the identity of the manufacturer of the drywall and the year of manufacture, from highest to lowest.

Knauf Plasterboard (Tianjin) Co. Ltd.: (year of manufacture 2005) China
Taian Taishan Plasterboard Co. Ltd.: (2006) China
Shandong Taihe Dongxin Co.: (2005) China
Knauf Plasterboard (Tianjin) Co. Ltd.: (2006) China
Taian Taishan Plasterboard Co. Ltd.: (2006) China
Taian Taishan Plasterboard Co. Ltd.: (2006) China
Shandong Chenxiang GBM Co. Ltd. (C&K Gypsum Board): (2006) China
Beijing New Building Materials (BNBM): (2009) China
Taian Taishan Plasterboard Co. Ltd.: (2009) China
Shandong Taihe Dongxin Co.: (2009) China
Other Chinese drywall samples had low or no detectable emissions of hydrogen sulfide as did the drywall samples tested that were manufactured domestically. They include: Knauf Plasterboard Tianjin: (2009) China; Tiger ***ShiGao JianCai***liangpianzhuang: (2006) China; USG Corporation: (2009) U.S.; Guangdong Knauf New Building Material Products Co. Ltd.: (2009) China; 3/8" drywall manufacturer uncertain (date uncertain): China; Knauf Plasterboard (Wuhu) Co. Ltd.: (2009) China; CertainTeed Corp.: (2009) U.S.; Georgia Pacific Corp.: (2009) U.S.; Dragon Brand, Beijing New Building Materials Co. Ltd.: (2006) China; CertainTeed Corp.: (2009) U.S.; Pingyi Baier Building Materials Co. Ltd.: (2009) China; Sample purchased in China, manufacturer unknown: (2009) China; Panel Rey S.A.: (2009) Mexico; Lafarge North America: (2009) U.S.; National Gypsum Company: (2009) U.S.; National Gypsum Company: (2009) U.S.; Georgia Pacific Corp.: (2009) U.S.; Pabco Gypsum: (2009) U.S.; Temple-Inland Inc.: (2009) U.S.; and USG Corporation: (2009) U.S.

Last month, CPSC released the results of drywall emissions tests by LBNL. The studies showed a connection between certain Chinese drywall and corrosion in homes. In addition, the patterns of reactive sulfur compounds emitted from drywall samples show a clear distinction between certain Chinese drywall samples manufactured in 2005/2006 and other Chinese and non-Chinese drywall samples.

To date, CPSC has spent over $5 million to investigate the chemical nature and the chain of commerce of problem drywall. Earlier this year, CPSC and HUD issued an identification protocol to help consumers identify problem drywall in their homes. Last month, CPSC and HUD issued remediation guidance to assist impacted homeowners.

See the chart (pdf) listing drywall chamber test results.

Monday, May 17, 2010

Consumers Warned of High Levels of Lead in Children's Jewellery

2010-80
May 17, 2010
For immediate release

The issue
Health Canada is advising consumers that high levels of lead continue to be found in a wide variety of children's jewellery products sold in Canada. Children can ingest harmful amounts of lead when they chew, suck or swallow jewellery items containing lead, as lead is very toxic to children even at low exposure levels. Simply wearing a jewellery item with lead does not present a serious risk to health because there is minimal lead absorption through the skin. In addition to lead, Health Canada is also concerned that cadmium, which is a carcinogen, may be increasingly substituted for lead in inexpensive children's jewellery.

Who is affected
Consumers purchasing inexpensive children's jewellery.

What consumers should do
•If you suspect your children's jewellery may contain lead or cadmium, throw it out in your regular household garbage. Consumers can also contact their municipality for instructions on disposing items containing lead.
•Do not give young children adult jewellery to wear or play with; it may contain lead or other heavy metals.
•Do not allow children to suck or chew on any jewellery.
•If your child has sucked or chewed regularly on jewellery which you think may contain lead or cadmium, ask your doctor to test your child's blood for lead or other heavy metals.
•A child who swallows a jewellery item containing lead is at high risk of developing severe poisoning. Contact an emergency medical service if you believe your child has swallowed an item containing lead or cadmium.
•Check for product recalls by contacting the retailer, manufacturer or Health Canada at www.healthcanada.gc.ca/cps-recalls.
•Additional information on lead in jewellery can be found on-line on the Consumer Product Safety web page.
Symptoms of Lead Poisoning
For more information on the risks and symptoms of lead exposure, visit Health Canada's: It's Your Health: Effects of Lead on Human Health.

Background
Several voluntary recalls for children's jewellery products have been published in the last few weeks. The sampling and testing phase of Health Canada's 2009/2010 Cyclical Enforcement testing on children's jewellery products concluded in March 2010 and the Department continues to work with industry to take the appropriate action on non-compliant products.

Under item 42, Part I of Schedule I of the Hazardous Products Act, it is illegal to import, advertise or sell jewellery items that appeal primarily to children under 15 years of age and contain more than 600 mg/kg total lead and 90 mg/kg migratable lead, which is the proportion of lead that is released from the product into the body under certain conditions, such as chewing, sucking, or swallowing of the product.

Lead contamination is not exclusive to metallic jewellery. Lead can be found in different materials used in jewellery manufacturing, such as some surface coatings as well as plastics like polyvinyl chloride (PVC). The level of lead found in a product can not be determined visually. Products labelled as "lead free" have been found to violate Health Canada's lead requirements.

For more information
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report problems with consumer products
Health Canada would like to remind Canadians to report any health or safety incidents related to the use of a consumer product or cosmetic. An easy-to-use incident report form is now available on the Department's website.

•E-mail: CPSR-RSPC@hc-sc.gc.ca
•Mail: Incident Report - Consumer Product Safety Directorate
Health Canada
123 Slater Street
Ottawa, ON, Canada, K1A 0K9

Thursday, May 6, 2010

The insanity of our times! A Comment.

We have gone over the cliff! Here is a clip from Progressive Grocer.

CSPI Threatens to Sue Safeway for Not Using loyalty Data for Recall Warnings

May 6, 2010

The Center for Science in the Public Interest (CSPI) yesterday notified Safeway that it would file a lawsuit against the grocery chain if it fails to adopt a policy to notify Club Card members who purchased contaminated food subject to recalls.

According to the Washington-based nonprofit health advocacy group, focuses on nutrition, food safety, and pro-health alcohol policies, even though Safeway collects phone numbers and e-mail addresses from its Club Card members, it won’t use that data to contact people who bought contaminated food.

“It shocks the conscience that a major retailer would sit on its hands, even though it has easy access to the e-mails, addresses and phone numbers of those who have purchased food that might be contaminated,” said CSPI litigation director Steve Gardner. “Perhaps Safeway saves a few pennies by remaining silent. But why would you knowingly risk letting your customers fall ill or, worse, die?”

CSPI said that many retailers use customer contact information generated by their bonus card programs to notify consumers when they’ve purchased recalled food, via letters and automated phone calls.


DO WE WANT EVERY COMPANY TO ISSUE THESE CARDS?

WHERE DO WE PUT ALL THESE CARDS?

Read more at:
http://www.progressivegrocer.com/progressivegrocer/content_display/supermarket-industry-news/e3i8af56baccdd2a1c6fc2c2578e87b4fbb

Information on Investigation into Pampers Dry Max Diapers

Information on Investigation into Pampers Dry Max Diapers

2010-68

May 5, 2010
For immediate release

OTTAWA - Health Canada has recently received two complaints of rashes that may have resulted from the use of Pampers Dry Max Diapers. Health Canada officials immediately contacted Procter and Gamble to follow up, and the investigation is now ongoing. Health Canada is also aware of the ongoing investigation in the United States, and is working cooperatively with US officials. Health Canada will post additional information as soon as it is available.

Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709

FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System

Media Inquiries: Dick Thompson, 301-796-7566; dick.thompson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Obtains Consent Decree to Stop Marketing of Unapproved Sterilization System

Steris agrees to stop selling SS1 tabletop system for endoscopes, other devices

The U.S. Food and Drug Administration today announced that a consent decree has been filed against the device manufacturer, STERIS Corp. of Mentor, Ohio. The decree stops the company from distributing unapproved and misbranded devices used to sterilize heat-sensitive instruments and medical devices. It prohibits the distribution of the STERIS System 1 Processor, or SS1, a tabletop liquid chemical system marketed to disinfect certain devices, such as endoscopes, that cannot withstand steam sterilization.

As part of the consent decree of permanent injunction, STERIS has developed a transition plan and rebate program for its U.S. customers to ease the transitioning to legally-marketed alternatives. The transition plan allows STERIS to continue to support existing customers who are using the SS1, but requires these customers to obtain a Certificate of Medical Necessity to get parts, components, accessories, and service during the transition period which ends on August 2, 2011.

“FDA’s oversight of medical devices helps ensure that patients are protected from unsafe or ineffective devices,” said Assistant Attorney General Tony West, who heads the Justice Department’s Civil Division. “When device manufacturers fail to comply with FDA’s regulations, they put patients at increased risk. As this consent decree shows, we will take whatever steps are necessary to make sure that all manufacturers are complying with FDA’s regulations.”

In May 2008, the FDA advised STERIS in a Warning Letter that significant changes made to the SS1 caused the device to be adulterated and misbranded. In December 2009, the FDA sent a letter to health care facilities and infection control practitioners advising them that the agency had not cleared the current version of the SS1. The letter recommended users transition to a legally-marketed alternative.

Under the consent decree, STERIS agreed to destroy used SS1 devices, components, parts, and accessories in the company’s possession within the United States by September 30, 2011. Some specified unused devices and component can, with FDA approval, be retained.

The decree was filed in the U.S. District Court, Northern District of Ohio on April 19, 2010, and is subject to court approval.

User facilities, including hospitals, are required to report suspected device-related deaths to the FDA and to the manufacturer, and serious injuries to the manufacturer or to FDA1.

In addition, healthcare professionals and consumers are encouraged to report serious adverse events that may be related to the use of unapproved and misbranded products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

On April 5, 2010, the FDA cleared the STERIS System 1E (SS1E), which is an alternative to the SS1. The SS1E is a liquid chemical sterilant processing system. Liquid chemical sterilization is not equivalent to traditional sterilization (such as steam, ethylene oxide, and gamma irradiation). The SS1E can be used to process reusable heat-sensitive devices such as endoscopes and their accessories that cannot be processed using steam.

Voluntary Reporting may be done:

Online2
Via Regular Mail: use postage-paid, pre-addressed Form FDA 35003. Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-332-1088

E. COLI VTEC NON-O157 - USA (02): (MICHIGAN, OHIO, NEW YORK) O145

E. COLI VTEC NON-O157 - USA (02): (MICHIGAN, OHIO, NEW YORK) O145
*****************************************************************
A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


Date: Mon 3 May 2010
Source: CIDRAP (Center for Infectious Disease Research & Policy) News [edited]



The strain of non-O157 _Escherichia coli_ that has caused recent illnesses
in Ohio, Michigan, and New York has been identified, but the food source
remains unknown, according to health officials. The Centers for Disease
Control and Prevention (CDC) has identified the strain as O145, which, like
O157, produces Shiga toxin, according to Jennifer House, spokeswoman for
the Ohio Department of Health.

A CDC team arrived in Ohio yesterday [2 May 2010] to assist in the
investigation, House told CIDRAP News.

http://www.promedmail.org/pls/apex/f?p=2400:1001:2227548857986884::NO::F2400_P1001_BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82570