Mandatory Meat Recall Legislation Introduced
U.S. Senator Tom Udall (D-NM) introduced legislation giving USDA authority to initiate mandatory meat product recalls.
“When the USDA cannot get tainted meat off the market swiftly, all our consumers are at risk,” said Udall. “This legislation will give USDA the authority to act quickly and decisively to protect the public.”
Under current law, USDA does not have the authority to issue a mandatory recall of meat believed to be dangerous.
The decision to recall or comply with requests from the USDA to recall unsafe products is left in the hands of food processors.
This forces the USDA to engage in time-consuming negotiations with meatpackers before pulling tainted meat from store shelves, and it gives meatpackers an effective veto on recalls.
Udall first introduced the legislation in 2003.
Thursday, July 30, 2009
Tanning beds now considered carcinogenic by international cancer group
Tanning beds now considered carcinogenic by international cancer group
In a policy report released Tuesday, the International Agency for Research on Cancer (IARC) announced that UV tanning beds have now been placed in the highest risk category -- group 1 -- and is considered "carcinogenic to humans."
Previously, tanning beds had been in group 2A, "probably carcinogenic to humans," according to the report in The Lancet Oncology for August. In addition to tanning beds, UVA, UVB, and UVC radiation were all moved from group 2A to group 1.
"The use of UV-emitting tanning devices is widespread in many developed countries, especially among young women," note Dr. Fatiha El Ghissassi in Lyons and colleagues from the IARC monograph working group.
The current change to the IARC's classification of tanning beds was prompted by a recent meta-analysis indicating that the odds of melanoma is increased by 75% when a person has been exposed to tanning beds before 30 years of age. Another factor in the change was the results of several case-control studies showing a link between tanning devices and ocular melanoma.
In addition to UV radiation, solar and all types of ionizing radiation (alpha- and beta-particle emitters, X-rays and gamma-rays, and neutron radiation) are now classified as group 1.
The report notes that there is "sufficient evidence" of increased melanoma risk in welders, but states that at this point it is unclear if this is due to UV radiation or to exposure to other harmful agents. Thus, a review of the carcinogenic risks of welding is warranted, the authors conclude.
In a policy report released Tuesday, the International Agency for Research on Cancer (IARC) announced that UV tanning beds have now been placed in the highest risk category -- group 1 -- and is considered "carcinogenic to humans."
Previously, tanning beds had been in group 2A, "probably carcinogenic to humans," according to the report in The Lancet Oncology for August. In addition to tanning beds, UVA, UVB, and UVC radiation were all moved from group 2A to group 1.
"The use of UV-emitting tanning devices is widespread in many developed countries, especially among young women," note Dr. Fatiha El Ghissassi in Lyons and colleagues from the IARC monograph working group.
The current change to the IARC's classification of tanning beds was prompted by a recent meta-analysis indicating that the odds of melanoma is increased by 75% when a person has been exposed to tanning beds before 30 years of age. Another factor in the change was the results of several case-control studies showing a link between tanning devices and ocular melanoma.
In addition to UV radiation, solar and all types of ionizing radiation (alpha- and beta-particle emitters, X-rays and gamma-rays, and neutron radiation) are now classified as group 1.
The report notes that there is "sufficient evidence" of increased melanoma risk in welders, but states that at this point it is unclear if this is due to UV radiation or to exposure to other harmful agents. Thus, a review of the carcinogenic risks of welding is warranted, the authors conclude.
Wednesday, July 29, 2009
Companies need to regain public trust, survey shows
2007 ARTICLE STILL RELEVANT TODAY.
Companies need to regain public trust, survey shows
Public apathy has set in over the safety of the food supply due to the soaring number of scares and recalls, according to a UK survey.
The implications are that companies need to do more to regain trust said Chris Woodcock, managing director of Razor Public Relations, which conducted the survey.
"It clearly indicates that more proactive risk management and reputation-building work needs to be done to recover trust and overcome the scepticism, particularly following some high-profile brand incidents in the first half of 2007," he said.
About 67 per cent of shoppers said they are hardly aware of national product alerts, according to Razor, which conducted the survey this month. Razor also found that only 17 per cent of UK consumers trust a manufacturer or reailer to give them accurate information on the scare or recall.
Processors and government may feel it is both their legal and moral responsibility to "tell it all and tell it fast" whenever a product emerges as a threat to human safety - especially if it is a food or drink and however theoretical the risk, Razor stated.
However the survey's statistics indicate that the approach to public alerts and recalls adopted by manufacturers and government advisory bodies may not be the correct way.
"Ironically, as the EU and UK regulatory and advisory authorities report soaring numbers of recall and safety reports in the last year, their effectiveness in terms of consumer safety seems to be diminishing as consumer apathy sets in," Razor Public Relations said in reporting on its survey.
The survey also found that 38 per cent cited regulatory bodies or independent authorities as the source they trust the most for product safety advice and information.
While only 17 per cent said they would trust a manufacturer's advice, 15 per cent said they would turn to the media for their information, and 13 per cent said they would trust the retailer.
The declining trust is mirrored by the low trust in the safety in the food supply. About 21 per cent of the survey sample said they feel less confident about food safety now than they did a year ago and 16 per cent said they "don't care about such alerts and don't take any notice of them".
The UK's Food Standards Agency investigated about 1,300 food safety incidents last year. Yet the survey shows only the minority of these, that progress into full-blown recalls, are getting the message across, said Woodcock.
In the last year to spring 2007, the Food Standards Agency dealt with 81 food alerts issued to local authorities and 478 notifications to the European Commission, through the EU's rapid alert system.
Other recent industry data demonstrates that recalls are also becoming increasingly international, with 48 per cent of European recalls involving products made in China, Woodcock said.
However the survey shows that the sheer volume of recalls and warnings is increasingly falling on deaf ears, he said.
"Although the advisory bodies might be mildly encouraged by our findings, this is a sharp blow for FMCG (Fast moving consumer goods) brands who have built up brand equity over many decades and who can suffer major dents in sales and loyalty as a result of recalls or other incidents," he said.
There are various reasons why product alert notifications are increasing, including the 2005 product safety legislation forcing manufacturers to be responsible for informing the authorities and consumers of any potential risk from their products.
In addition companies feel they need to live up to their corporate and social responsibility commitments, by doing - and being seen to do - the right thing, he said.
EU legislation that came into effect in 2002 required more public alert reporting and established new procedures in food safety back in 2002. Articles in the legislation relating to traceability and transparency forced manufacturers to be more open about product recalls, Woodcock noted.
Meanwhile, across the Atlantic, the US Food and Drug Administration (FDA) established a new advisory committee last month to counsel the regulator on how to strengthen the communication to the public.
The advisory body will ake recommendations to the FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information.
"There is an obligation for legal and regulatory compliance, that manufacturers are heeding," Woodcock stated. "But there is also a much greater need for pre-emptive risk management work to prevent incidents arising or to mitigate their effects, both on the consumer and on the brand, when they do occur."
The UK survey was carried out on 1,000 people above the age of 16 over the weekend of 13 to 15 July 2007 by independent research body, BMRB International.
FULL STORY: http://www.foodqualitynews.com/Public-Concerns/Companies-need-to-regain-public-trust-survey-shows
Companies need to regain public trust, survey shows
Public apathy has set in over the safety of the food supply due to the soaring number of scares and recalls, according to a UK survey.
The implications are that companies need to do more to regain trust said Chris Woodcock, managing director of Razor Public Relations, which conducted the survey.
"It clearly indicates that more proactive risk management and reputation-building work needs to be done to recover trust and overcome the scepticism, particularly following some high-profile brand incidents in the first half of 2007," he said.
About 67 per cent of shoppers said they are hardly aware of national product alerts, according to Razor, which conducted the survey this month. Razor also found that only 17 per cent of UK consumers trust a manufacturer or reailer to give them accurate information on the scare or recall.
Processors and government may feel it is both their legal and moral responsibility to "tell it all and tell it fast" whenever a product emerges as a threat to human safety - especially if it is a food or drink and however theoretical the risk, Razor stated.
However the survey's statistics indicate that the approach to public alerts and recalls adopted by manufacturers and government advisory bodies may not be the correct way.
"Ironically, as the EU and UK regulatory and advisory authorities report soaring numbers of recall and safety reports in the last year, their effectiveness in terms of consumer safety seems to be diminishing as consumer apathy sets in," Razor Public Relations said in reporting on its survey.
The survey also found that 38 per cent cited regulatory bodies or independent authorities as the source they trust the most for product safety advice and information.
While only 17 per cent said they would trust a manufacturer's advice, 15 per cent said they would turn to the media for their information, and 13 per cent said they would trust the retailer.
The declining trust is mirrored by the low trust in the safety in the food supply. About 21 per cent of the survey sample said they feel less confident about food safety now than they did a year ago and 16 per cent said they "don't care about such alerts and don't take any notice of them".
The UK's Food Standards Agency investigated about 1,300 food safety incidents last year. Yet the survey shows only the minority of these, that progress into full-blown recalls, are getting the message across, said Woodcock.
In the last year to spring 2007, the Food Standards Agency dealt with 81 food alerts issued to local authorities and 478 notifications to the European Commission, through the EU's rapid alert system.
Other recent industry data demonstrates that recalls are also becoming increasingly international, with 48 per cent of European recalls involving products made in China, Woodcock said.
However the survey shows that the sheer volume of recalls and warnings is increasingly falling on deaf ears, he said.
"Although the advisory bodies might be mildly encouraged by our findings, this is a sharp blow for FMCG (Fast moving consumer goods) brands who have built up brand equity over many decades and who can suffer major dents in sales and loyalty as a result of recalls or other incidents," he said.
There are various reasons why product alert notifications are increasing, including the 2005 product safety legislation forcing manufacturers to be responsible for informing the authorities and consumers of any potential risk from their products.
In addition companies feel they need to live up to their corporate and social responsibility commitments, by doing - and being seen to do - the right thing, he said.
EU legislation that came into effect in 2002 required more public alert reporting and established new procedures in food safety back in 2002. Articles in the legislation relating to traceability and transparency forced manufacturers to be more open about product recalls, Woodcock noted.
Meanwhile, across the Atlantic, the US Food and Drug Administration (FDA) established a new advisory committee last month to counsel the regulator on how to strengthen the communication to the public.
The advisory body will ake recommendations to the FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information.
"There is an obligation for legal and regulatory compliance, that manufacturers are heeding," Woodcock stated. "But there is also a much greater need for pre-emptive risk management work to prevent incidents arising or to mitigate their effects, both on the consumer and on the brand, when they do occur."
The UK survey was carried out on 1,000 people above the age of 16 over the weekend of 13 to 15 July 2007 by independent research body, BMRB International.
FULL STORY: http://www.foodqualitynews.com/Public-Concerns/Companies-need-to-regain-public-trust-survey-shows
Tuesday, July 28, 2009
Food recalls getting more complex
Food recalls getting more complex
Despite the headlines and public perception, Canadians aren’t being forced by more food recalls to purge their pantries of questionable food, a Brock University professor says.
But Michael Armstrong, who teaches courses in quality and operations management, said the recalls Canadians are being hit with are becoming more complex, thanks to seemingly never-ending additions to lists of products containing questionable ingredients.
Take the recall of peanuts contaminated by salmonella. The initial recall of Peanut Corp. of America nuts was issued in January.
Armstrong, a regular visitor to the website of the Canadian Food Inspection Agency, which issues the recalls, said another notice about products that may contain the dodgy nuts was posted in June.
Armstrong started crunching the CFIA’s recall numbers earlier this year after hearing people muse that warnings about contaminated food seemed to be more common.
Since 2004, the CFIA has issued 696 alerts, Armstrong found. Fifty-six per cent were “Health Hazard Alerts” — food recalls — while 41 per cent were allergy alerts. Only three per cent contained other advice.
Suspected contamination by bacteria was the cause of 67 per cent of those recalls, including listeria (22 per cent), salmonella (19 per cent) and E. coli (10 per cent).
While Armstrong discovered that the average number of alerts the CFIA issues each month has tripled from an average 7.5 in 2004 to 20.7 in early 2009, they aren’t all about a new problem. Some described expansions or updates of previous alerts, implying the recalls increased in size and complexity more than frequency.
“There were so many alerts because there were so many products, so many brand names, and unfortunately, some of those companies don’t access their records as quickly as others,”
Armstrong said. “Not very good traceability in those cases.”
His point isn’t to cause panic, he said.
“I don’t think it’s something consumers should go home worrying about but ... we should be asking our companies and our governments to put more resources into making sure this is investigated and taken care of,” Armstrong said.
FULL STORY:http://www.stcatharinesstandard.ca/ArticleDisplay.aspx?e=1676396
Despite the headlines and public perception, Canadians aren’t being forced by more food recalls to purge their pantries of questionable food, a Brock University professor says.
But Michael Armstrong, who teaches courses in quality and operations management, said the recalls Canadians are being hit with are becoming more complex, thanks to seemingly never-ending additions to lists of products containing questionable ingredients.
Take the recall of peanuts contaminated by salmonella. The initial recall of Peanut Corp. of America nuts was issued in January.
Armstrong, a regular visitor to the website of the Canadian Food Inspection Agency, which issues the recalls, said another notice about products that may contain the dodgy nuts was posted in June.
Armstrong started crunching the CFIA’s recall numbers earlier this year after hearing people muse that warnings about contaminated food seemed to be more common.
Since 2004, the CFIA has issued 696 alerts, Armstrong found. Fifty-six per cent were “Health Hazard Alerts” — food recalls — while 41 per cent were allergy alerts. Only three per cent contained other advice.
Suspected contamination by bacteria was the cause of 67 per cent of those recalls, including listeria (22 per cent), salmonella (19 per cent) and E. coli (10 per cent).
While Armstrong discovered that the average number of alerts the CFIA issues each month has tripled from an average 7.5 in 2004 to 20.7 in early 2009, they aren’t all about a new problem. Some described expansions or updates of previous alerts, implying the recalls increased in size and complexity more than frequency.
“There were so many alerts because there were so many products, so many brand names, and unfortunately, some of those companies don’t access their records as quickly as others,”
Armstrong said. “Not very good traceability in those cases.”
His point isn’t to cause panic, he said.
“I don’t think it’s something consumers should go home worrying about but ... we should be asking our companies and our governments to put more resources into making sure this is investigated and taken care of,” Armstrong said.
FULL STORY:http://www.stcatharinesstandard.ca/ArticleDisplay.aspx?e=1676396
FDA Issues Final Regulation on Dental Amalgam
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Issues Final Regulation on Dental Amalgam
The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.
The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.
The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.
Specifically, the FDA recommended that the product labeling include:
A warning against the use of dental amalgam in patients with mercury allergy;
A warning that dental professionals use adequate ventilation when handling dental amalgam;
A statement discussing the scientific evidence on the benefits and risk of dental amalgam,
including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.
Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required
the FDA to issue regulations classifying pre-amendment devices according to their risk into class
I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.
Today’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).
Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.
In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.
Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.
The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.
On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.
FDA’s Web site on dental amalgam:http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm
Consumer Inquiries: 888-INFO-FDA
FDA Issues Final Regulation on Dental Amalgam
The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.
The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.
The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.
Specifically, the FDA recommended that the product labeling include:
A warning against the use of dental amalgam in patients with mercury allergy;
A warning that dental professionals use adequate ventilation when handling dental amalgam;
A statement discussing the scientific evidence on the benefits and risk of dental amalgam,
including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.
Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required
the FDA to issue regulations classifying pre-amendment devices according to their risk into class
I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.
Today’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).
Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.
In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.
Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.
The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.
On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.
FDA’s Web site on dental amalgam:http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm
Tuesday, July 21, 2009
Entire Oregon Coast now closed to recreational mussel harvesting
Entire Oregon Coast now closed to recreational mussel harvesting
The Oregon Department of Agriculture has extended the area closed to recreational mussel harvesting to include the entire coast, from the mouth of the Columbia River to the California border. The closure is due to elevated levels of paralytic shellfish poisoning or PSP toxins and includes mussels on all beaches, rocks, jetties, and at the entrance to bays along the Oregon Coast.
Coastal scallops are not affected by this closure when only the adductor muscle is eaten. The consumption of whole recreationally harvested scallops is not recommended. Crab are not affected by this level of toxin and are safe to eat.
Shellfish contaminated with PSP toxins can cause minor to severe illness or even death. The symptoms usually begin with tingling of the mouth and tongue. Severe poisoning can result in dizziness, numbness and tingling in the arms and legs, paralysis of the arms and legs, and paralysis of the muscles used for breathing. Shellfish toxins are produced by algae and usually originate in the ocean.
ODA will continue to test for shellfish toxins weekly, as tides permit. Reopening of an area requires two consecutive tests in the safe range.
For more information, call ODA's shellfish safety information hotline at (800) 448-2474, the Food Safety Division at (503) 986-4720 or visit the ODA shellfish closures Web page.
The Oregon Department of Agriculture has extended the area closed to recreational mussel harvesting to include the entire coast, from the mouth of the Columbia River to the California border. The closure is due to elevated levels of paralytic shellfish poisoning or PSP toxins and includes mussels on all beaches, rocks, jetties, and at the entrance to bays along the Oregon Coast.
Coastal scallops are not affected by this closure when only the adductor muscle is eaten. The consumption of whole recreationally harvested scallops is not recommended. Crab are not affected by this level of toxin and are safe to eat.
Shellfish contaminated with PSP toxins can cause minor to severe illness or even death. The symptoms usually begin with tingling of the mouth and tongue. Severe poisoning can result in dizziness, numbness and tingling in the arms and legs, paralysis of the arms and legs, and paralysis of the muscles used for breathing. Shellfish toxins are produced by algae and usually originate in the ocean.
ODA will continue to test for shellfish toxins weekly, as tides permit. Reopening of an area requires two consecutive tests in the safe range.
For more information, call ODA's shellfish safety information hotline at (800) 448-2474, the Food Safety Division at (503) 986-4720 or visit the ODA shellfish closures Web page.
Feds Seize Kentucky Livestock Kept In "Filthy Conditions"- Inspections found rodent infestation, feces, urine
Feds Seize Kentucky Livestock Kept In "Filthy Conditions"
Inspections found rodent infestation, feces, urine
Federal marshals today seized livestock and horse feeds stored in filthy and rodent-ridden conditions at the Bi-County Farm Bureau Cooperative Association, Inc., in Florence, Kentucky.
The action was triggered by a request from the U.S. Food and Drug Administration (FDA) and a federal warrant issued by the U.S. District Court in the Eastern District of Kentucky.
"The FDA will not tolerate a company's failure to adequately control and prevent filth in its facility," Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, said in a statement. "The FDA is prepared to use whatever legal means are necessary and appropriate to keep potentially contaminated products out of the marketplace."
During a recent inspection of Bi-County feed mill, FDA inspections discovered live and dead mice and evidence of bird activity throughout the facility. Laboratory analysis of samples collected during the inspection confirmed the presence of rodent urine, rodent feces, rodent hairs, and rodent-gnawed holes in bags, according to the FDA.
Under the federal warrant issued, marshals seized all FDA-regulated food products exposed to rodent and bird contamination at the facility. The FDA said the seized products violate the Federal Food, Drug, and Cosmetic Act because they were "kept in conditions in which they may have become contaminated with filth."
Bi-County manufactures feed and stores commercial feeds received through interstate commerce, the FDA said. The facility's more than 50 products are sold locally to farms and stables.
Consumers who bought the products should not feed them to animals, the FDA said.
Read more: http://www.consumeraffairs.com/news04/2009/07/ky_livestock_feds.html#ixzz0LtsGWZRp
Inspections found rodent infestation, feces, urine
Federal marshals today seized livestock and horse feeds stored in filthy and rodent-ridden conditions at the Bi-County Farm Bureau Cooperative Association, Inc., in Florence, Kentucky.
The action was triggered by a request from the U.S. Food and Drug Administration (FDA) and a federal warrant issued by the U.S. District Court in the Eastern District of Kentucky.
"The FDA will not tolerate a company's failure to adequately control and prevent filth in its facility," Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, said in a statement. "The FDA is prepared to use whatever legal means are necessary and appropriate to keep potentially contaminated products out of the marketplace."
During a recent inspection of Bi-County feed mill, FDA inspections discovered live and dead mice and evidence of bird activity throughout the facility. Laboratory analysis of samples collected during the inspection confirmed the presence of rodent urine, rodent feces, rodent hairs, and rodent-gnawed holes in bags, according to the FDA.
Under the federal warrant issued, marshals seized all FDA-regulated food products exposed to rodent and bird contamination at the facility. The FDA said the seized products violate the Federal Food, Drug, and Cosmetic Act because they were "kept in conditions in which they may have become contaminated with filth."
Bi-County manufactures feed and stores commercial feeds received through interstate commerce, the FDA said. The facility's more than 50 products are sold locally to farms and stables.
Consumers who bought the products should not feed them to animals, the FDA said.
Read more: http://www.consumeraffairs.com/news04/2009/07/ky_livestock_feds.html#ixzz0LtsGWZRp
Health Canada Advises Canadians of Dangerous Garden Torches
Health Canada Advises Canadians of Dangerous Garden Torches
Advisory2009-119
With the outdoor living and entertainment season upon us, Canadians should exercise caution when purchasing decorative refillable garden torches such as tiki torches. Garden torches must meet the federal safety standards regarding child-resistant closures and safety labelling.
Through ongoing inspections over the past two years, Health Canada has identified numerous garden torches that do not meet Canadian safety requirements. Health Canada has taken action to remove these non-compliant torches from the marketplace, and will continue to do so.
Torches are sold with an empty metal or glass reservoir which uses either liquid paraffin, lamp oil, citronella or kerosene, as a fuel. The thin, water-like fuel sources are hazardous when ingested and therefore require child-resistant closures. For safety and flammability reasons, many of these fuels also require special labelling to appear on the reservoir of the torch.
Consumers should pay close attention to the closures and labelling of the torch reservoirs when purchasing garden torches. Canadians should also dispose of any items that do not have the proper closures and if needed, dispose of the accompanying fuels in accordance with applicable federal, provincial and municipal laws.
Garden torches should be kept out of the reach of children, as per the labelling instructions. Health Canada has not received any reports of injuries related to these torches. Nevertheless, the Department advises the public not to use any non-compliant garden torches.
Consumers are encouraged to notify Health Canada should they identify a product that they suspect is non-compliant product and contact their nearest Health Canada Product Safety office by phone at 1-866-662-0666 (toll-free) or email at cps_spc@hc-sc.gc.ca (Please note the store and province or territory where the product was found).
Additional information, including a summary of some of the safety requirements for these products, can be found in Health Canada 's Consumer Information Bulletin on Decorative Refillable Outdoor Torches.
If you would like to receive updates on consumer advisories and product recalls, you may subscribe to Health Canada 's Consumer Product Safety News listserv by sending an e-mail to:
cpsn-nspc-subscribe@list.hc-sc.gc.ca
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Advisory2009-119
With the outdoor living and entertainment season upon us, Canadians should exercise caution when purchasing decorative refillable garden torches such as tiki torches. Garden torches must meet the federal safety standards regarding child-resistant closures and safety labelling.
Through ongoing inspections over the past two years, Health Canada has identified numerous garden torches that do not meet Canadian safety requirements. Health Canada has taken action to remove these non-compliant torches from the marketplace, and will continue to do so.
Torches are sold with an empty metal or glass reservoir which uses either liquid paraffin, lamp oil, citronella or kerosene, as a fuel. The thin, water-like fuel sources are hazardous when ingested and therefore require child-resistant closures. For safety and flammability reasons, many of these fuels also require special labelling to appear on the reservoir of the torch.
Consumers should pay close attention to the closures and labelling of the torch reservoirs when purchasing garden torches. Canadians should also dispose of any items that do not have the proper closures and if needed, dispose of the accompanying fuels in accordance with applicable federal, provincial and municipal laws.
Garden torches should be kept out of the reach of children, as per the labelling instructions. Health Canada has not received any reports of injuries related to these torches. Nevertheless, the Department advises the public not to use any non-compliant garden torches.
Consumers are encouraged to notify Health Canada should they identify a product that they suspect is non-compliant product and contact their nearest Health Canada Product Safety office by phone at 1-866-662-0666 (toll-free) or email at cps_spc@hc-sc.gc.ca (Please note the store and province or territory where the product was found).
Additional information, including a summary of some of the safety requirements for these products, can be found in Health Canada 's Consumer Information Bulletin on Decorative Refillable Outdoor Torches.
If you would like to receive updates on consumer advisories and product recalls, you may subscribe to Health Canada 's Consumer Product Safety News listserv by sending an e-mail to:
cpsn-nspc-subscribe@list.hc-sc.gc.ca
Media Enquiries:Health Canada(613) 957-2983
Public Enquiries:(613) 957-29911-866 225-0709
Friday, July 17, 2009
Haier America to Pay More Than $500,000 Civil Penalty- Company Recalled 150,000 Fans Due to Fire Hazard
Haier America to Pay More Than $500,000 Civil Penalty
Company Recalled 150,000 Fans Due to Fire Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Haier America Trading LLC, of New York City, has agreed to pay a civil penalty of $587,500 to settle allegations that the appliance manufacturer failed to inform CPSC of a defect and fire hazard in the company’s Oscillating Tower Fan, model FTM140GG.
The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Haier America knowingly failed to report to CPSC immediately, as required by federal law, that the fan posed a risk of fire. Repeated bending of the fan’s wires during oscillation caused the wires to break, resulting in a fire hazard.
From May 2004 to October 2004, Haier America received as many as 14 reports of incidents involving the fans, including some fires and one report of injuries. During that time, Haier America conducted testing and other analysis. Haier America finally reported to CPSC in December 2004, only after CPSC asked the company to report. In November 2005, Haier America and CPSC announced a recall of the fans.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or violates any consumer product safety rule or any other rule, regulation, standard, or ban enforced by the CPSC.
“Prompt reporting in this case could have prevented fires and injuries,” said CPSC Chairman Inez Tenenbaum. “Companies have a responsibility to immediately let us know of potential hazards, and we will hold them to their duty.”
In agreeing to the settlement, Haier America denies CPSC's allegations.
Company Recalled 150,000 Fans Due to Fire Hazard
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that Haier America Trading LLC, of New York City, has agreed to pay a civil penalty of $587,500 to settle allegations that the appliance manufacturer failed to inform CPSC of a defect and fire hazard in the company’s Oscillating Tower Fan, model FTM140GG.
The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Haier America knowingly failed to report to CPSC immediately, as required by federal law, that the fan posed a risk of fire. Repeated bending of the fan’s wires during oscillation caused the wires to break, resulting in a fire hazard.
From May 2004 to October 2004, Haier America received as many as 14 reports of incidents involving the fans, including some fires and one report of injuries. During that time, Haier America conducted testing and other analysis. Haier America finally reported to CPSC in December 2004, only after CPSC asked the company to report. In November 2005, Haier America and CPSC announced a recall of the fans.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or violates any consumer product safety rule or any other rule, regulation, standard, or ban enforced by the CPSC.
“Prompt reporting in this case could have prevented fires and injuries,” said CPSC Chairman Inez Tenenbaum. “Companies have a responsibility to immediately let us know of potential hazards, and we will hold them to their duty.”
In agreeing to the settlement, Haier America denies CPSC's allegations.
Wednesday, July 15, 2009
The MedWatch June 2009 Drug Safety Labeling Changes posting includes 31 drug products with safety labeling changes
The MedWatch June 2009 Drug Safety Labeling Changes posting includes 31 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm153825.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Prometrium (progesterone), Reglan (metoclopramide), Coreg (carvedilol), Prandin (repaglinide), Videx (didanosine), Amaryl (glimepiride), Aristospan (triamcinolone hexacetonide injectable suspension, USP), Cancidas (caspofungin acetate), CellCept (mycophenolate mofetil), Combivent (ipratropium bromide and albuterol sulfate), Coreg CR (carvedilol phosphate), Patanase (olopatadine hydrochloride), Rocephin (ceftriaxone sodium), Strattera (atomoxetine hydrochloride)
The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm153825.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Prometrium (progesterone), Reglan (metoclopramide), Coreg (carvedilol), Prandin (repaglinide), Videx (didanosine), Amaryl (glimepiride), Aristospan (triamcinolone hexacetonide injectable suspension, USP), Cancidas (caspofungin acetate), CellCept (mycophenolate mofetil), Combivent (ipratropium bromide and albuterol sulfate), Coreg CR (carvedilol phosphate), Patanase (olopatadine hydrochloride), Rocephin (ceftriaxone sodium), Strattera (atomoxetine hydrochloride)
Tuesday, July 14, 2009
FDA Takes Action on Darvon and Other Pain Medications
FDA Takes Action on Darvon and Other Pain Medications
On July 7, 2009, the Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet.
These medications contain the drug propoxyphene, which is linked to death from overdoses.
FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug’s potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.
FDA ActionsFDA is requiring manufacturers of propoxyphene-containing products to strengthen the label’s boxed warning to emphasize the risk for overdose when using these products.
FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.
FDA is planning to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.
FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.About PropoxyphenePropoxyphene has been on the market since 1957.It is a widely prescribed medication in a group of drugs known as opioids, and is used to treat mild to moderate pain.
The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.Advice for ConsumersBe aware of all the risks associated with pain medication, including propoxyphene, when making decisions on how to treat pain. All pain medicines have side effects.Talk to your health care professional to decide on the appropriate pain treatment for you if you need relief from pain.
On July 7, 2009, the Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet.
These medications contain the drug propoxyphene, which is linked to death from overdoses.
FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug’s potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.
FDA ActionsFDA is requiring manufacturers of propoxyphene-containing products to strengthen the label’s boxed warning to emphasize the risk for overdose when using these products.
FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.
FDA is planning to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.
FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.About PropoxyphenePropoxyphene has been on the market since 1957.It is a widely prescribed medication in a group of drugs known as opioids, and is used to treat mild to moderate pain.
The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting.Advice for ConsumersBe aware of all the risks associated with pain medication, including propoxyphene, when making decisions on how to treat pain. All pain medicines have side effects.Talk to your health care professional to decide on the appropriate pain treatment for you if you need relief from pain.
Saturday, July 11, 2009
New law requires food processors to have written recall plan
New law requires food processors to have written recall plan
Panola Pepper Corp.’s Grady “Bubber” Brown said his company has had a food recall plan in place for years.
“We’ve never had to recall a product, thank goodness, but I think it’s important that every manufacturer have a plan to protect their customers and distributors,” said Brown, whose Lake Providence company produces almost 75 hot sauces and spice mixes.
Soon, every Louisiana food processor will be required to have a plan similar to Panola’s after Gov. Bobby Jindal signed state Sen. Francis Thompson’s food safety bill (SB 93) into law this week.
The new law requires all food processors to maintain a written food recall plan and report instances of contamination to the state Department of Health and Hospitals within 24 hours of when the processor learned of the contamination beginning Jan. 1, 2011.
About one in four Americans get sick every year due to food-borne illness and as many as 5,000 die, according to the U.S. government.
“It shocked me to find out how many people get sick and die each year,” said Thompson, D-Delhi. “You can’t open the newspaper without reading about another problem with food.
“It’s an issue we have to deal with, and I felt like the state needed to get up to speed.”
Thompson, who is chairman of the Senate Agriculture Committee, is scheduled to speak about the issue at the Southern Legislative Conference in Winston-Salem, N.C., next month.
“I think it’s the right thing to do at the right time,” Thompson said. “We have to protect our residents.”
The new Louisiana law was especially timely after President Obama said this week the federal government will try to boost the safety of some of the nation’s most popular foods, announcing stricter rules for the production of eggs, poultry, beef, leafy greens, melons and tomatoes.
Those new standards are an effort to reduce instances of salmonella and E. coli contamination.
The group, headed by Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius, is also directing the Food and Drug Administration to help the food industry establish better tracing systems if there is an outbreak, so the origins of a disease can be quickly found.
A new network to help the many agencies that regulate food safety communicate better will also be created.
Earlier this year a massive salmonella outbreak in peanut products sickened hundreds, was suspected of causing nine deaths and led to one of the largest product recalls in U.S. history. In the past month, Nestle Toll House cookie dough and 380,000 pounds of beef produced by the JBS Swift Beef Co. of Greeley, Colo., have been recalled due illnesses caused by E. coli contamination.
Brown said all of Panola’s products have a date and code and record of where they are shipped.
“It’s important for safety, but it’s also important to the people we do business with,” Brown said. “They want to know that we can act quickly if necessary.”
Panola Pepper Corp.’s Grady “Bubber” Brown said his company has had a food recall plan in place for years.
“We’ve never had to recall a product, thank goodness, but I think it’s important that every manufacturer have a plan to protect their customers and distributors,” said Brown, whose Lake Providence company produces almost 75 hot sauces and spice mixes.
Soon, every Louisiana food processor will be required to have a plan similar to Panola’s after Gov. Bobby Jindal signed state Sen. Francis Thompson’s food safety bill (SB 93) into law this week.
The new law requires all food processors to maintain a written food recall plan and report instances of contamination to the state Department of Health and Hospitals within 24 hours of when the processor learned of the contamination beginning Jan. 1, 2011.
About one in four Americans get sick every year due to food-borne illness and as many as 5,000 die, according to the U.S. government.
“It shocked me to find out how many people get sick and die each year,” said Thompson, D-Delhi. “You can’t open the newspaper without reading about another problem with food.
“It’s an issue we have to deal with, and I felt like the state needed to get up to speed.”
Thompson, who is chairman of the Senate Agriculture Committee, is scheduled to speak about the issue at the Southern Legislative Conference in Winston-Salem, N.C., next month.
“I think it’s the right thing to do at the right time,” Thompson said. “We have to protect our residents.”
The new Louisiana law was especially timely after President Obama said this week the federal government will try to boost the safety of some of the nation’s most popular foods, announcing stricter rules for the production of eggs, poultry, beef, leafy greens, melons and tomatoes.
Those new standards are an effort to reduce instances of salmonella and E. coli contamination.
The group, headed by Agriculture Secretary Tom Vilsack and Health and Human Services Secretary Kathleen Sebelius, is also directing the Food and Drug Administration to help the food industry establish better tracing systems if there is an outbreak, so the origins of a disease can be quickly found.
A new network to help the many agencies that regulate food safety communicate better will also be created.
Earlier this year a massive salmonella outbreak in peanut products sickened hundreds, was suspected of causing nine deaths and led to one of the largest product recalls in U.S. history. In the past month, Nestle Toll House cookie dough and 380,000 pounds of beef produced by the JBS Swift Beef Co. of Greeley, Colo., have been recalled due illnesses caused by E. coli contamination.
Brown said all of Panola’s products have a date and code and record of where they are shipped.
“It’s important for safety, but it’s also important to the people we do business with,” Brown said. “They want to know that we can act quickly if necessary.”
Friday, July 10, 2009
Before having garage sale, check if items recalled
Before Garage Sale, Beware Of Recalled Items
Garage sale operators cannot sell recalled products, under a recent law change.
You could be breaking the law just by selling certain items.
It's hard to believe you can actually get into trouble just by having a garage sale. It's easy to do, Tucker says, because she almost did it. Tucker was about to sell magnetic toys she bought for her children several years ago, until an estate sale expert advised her to do some homework.
"Go online and check to see if (a type of item) has been recalled," Diane Hudec said. "If it has, throw it away." In fact, it's illegal to sell a recalled item at a garage sale, a yard sale or even on the Internet.
It's a new law that was signed just last year.
Whether you're selling toys, baby products, baby furniture, or any other items you need to make sure they have not been recalled.
Where do you look? http://www.totalrecallinfo.com/freerecalls.php
It's a tough law to enforce because the agency doesn't have the people to go around checking garage sales. But if someone turns you in, you could face a fine.
Garage sale operators cannot sell recalled products, under a recent law change.
You could be breaking the law just by selling certain items.
It's hard to believe you can actually get into trouble just by having a garage sale. It's easy to do, Tucker says, because she almost did it. Tucker was about to sell magnetic toys she bought for her children several years ago, until an estate sale expert advised her to do some homework.
"Go online and check to see if (a type of item) has been recalled," Diane Hudec said. "If it has, throw it away." In fact, it's illegal to sell a recalled item at a garage sale, a yard sale or even on the Internet.
It's a new law that was signed just last year.
Whether you're selling toys, baby products, baby furniture, or any other items you need to make sure they have not been recalled.
Where do you look? http://www.totalrecallinfo.com/freerecalls.php
It's a tough law to enforce because the agency doesn't have the people to go around checking garage sales. But if someone turns you in, you could face a fine.
FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
Companies failed to declare allergens in products and correct filthy conditions
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.
The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.
The government's complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.
The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.
During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.
FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.
In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.
“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”
Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
Consumer Inquiries: 888-INFO-FDA
FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
Companies failed to declare allergens in products and correct filthy conditions
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.
The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.
The government's complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.
The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.
During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.
FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.
In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.
“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”
Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
Thursday, July 9, 2009
FDA Takes Enforcement Action Against Cheese Manufacturer
Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Takes Enforcement Action Against Cheese Manufacturer
Company failed to correct violations despite being advised by federal officials to do so and fines by state officials
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, today filed a complaint seeking injunctive relief against Peregrina Cheese, Inc., (Peregrina Cheese), Brooklyn, N.Y. and two of its officers: Javier Peregrina and Isabel Peregrina.
The company prepares and processes a variety of cheeses, sour cream, flan and gelatin products and distributes them to specialty grocery stores in northeastern Pennsylvania and in the New York City area.
The government's complaint, filed today in the Eastern District of New York, alleges that the company has an extensive history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes. Listeria is a foodborne pathogen that can cause serious illness and death.
If entered by the court, the injunction would temporarily stop the company and its officers from manufacturing and distributing food until further action is taken by the court.
“This company has consistently failed to make corrections to improve the insanitary conditions under which it processes cheese products, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate food companies that fail to provide adequate safeguards.”
"When called upon by the FDA, the Department of Justice is ready and able to prevent the distribution of adulterated food to American consumers," said Tony West, Assistant Attorney General for the Justice Department's Civil Division.
“The public must be able to trust that the food in their grocery stores is safe for them to eat,” said Benton J. Campbell, the United States Attorney for the Eastern District of New York. “We will continue to work with the FDA to ensure that companies that produce food under dangerous or insanitary conditions take corrective action to clean up their act.”
As alleged in the complaint, on numerous occasions since 2004, FDA investigators found Listeria monocytogenes in finished cheese products and inside Peregrina Cheese’s facility. Additionally, routine laboratory testing by New York State Department of Agriculture and Markets
(NYSDAM) also found Listeria in the company’s products on numerous occasions since 2003.
The FDA and NYSDAM inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found filthy conditions, standing water in food processing equipment, workers inappropriately dressed and a dead rodent inside the plant.
The government’s complaint alleges that both the FDA and NYSDAM repeatedly advised Peregrina Cheese and its officers of their cGMP violations; NYSDAM has also assessed fines against the company.
Peregrina Cheese’s lack of effective measures to bring its food processing operations into compliance with the law poses a public health threat because of the potential that Listeria will be in the food processed by the company.
Listeriosis, the illness caused by Listeria monocytogenes, can be serious and sometimes cause fatal infections in young children, frail or older people, and others with weakened immune systems. Although healthy individuals may experience only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection in pregnant women can cause miscarriages and stillbirths.
No illnesses have been reported to date from Peregrina Cheese products. However, if individuals have eaten the products and are experiencing any of the symptoms listed above, they should contact their health care professional.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
Consumer Inquiries: 888-INFO-FDA
FDA Takes Enforcement Action Against Cheese Manufacturer
Company failed to correct violations despite being advised by federal officials to do so and fines by state officials
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, today filed a complaint seeking injunctive relief against Peregrina Cheese, Inc., (Peregrina Cheese), Brooklyn, N.Y. and two of its officers: Javier Peregrina and Isabel Peregrina.
The company prepares and processes a variety of cheeses, sour cream, flan and gelatin products and distributes them to specialty grocery stores in northeastern Pennsylvania and in the New York City area.
The government's complaint, filed today in the Eastern District of New York, alleges that the company has an extensive history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes. Listeria is a foodborne pathogen that can cause serious illness and death.
If entered by the court, the injunction would temporarily stop the company and its officers from manufacturing and distributing food until further action is taken by the court.
“This company has consistently failed to make corrections to improve the insanitary conditions under which it processes cheese products, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate food companies that fail to provide adequate safeguards.”
"When called upon by the FDA, the Department of Justice is ready and able to prevent the distribution of adulterated food to American consumers," said Tony West, Assistant Attorney General for the Justice Department's Civil Division.
“The public must be able to trust that the food in their grocery stores is safe for them to eat,” said Benton J. Campbell, the United States Attorney for the Eastern District of New York. “We will continue to work with the FDA to ensure that companies that produce food under dangerous or insanitary conditions take corrective action to clean up their act.”
As alleged in the complaint, on numerous occasions since 2004, FDA investigators found Listeria monocytogenes in finished cheese products and inside Peregrina Cheese’s facility. Additionally, routine laboratory testing by New York State Department of Agriculture and Markets
(NYSDAM) also found Listeria in the company’s products on numerous occasions since 2003.
The FDA and NYSDAM inspections also revealed that the company repeatedly violated the current Good Manufacturing Practice (cGMP) requirements for foods. Investigators found filthy conditions, standing water in food processing equipment, workers inappropriately dressed and a dead rodent inside the plant.
The government’s complaint alleges that both the FDA and NYSDAM repeatedly advised Peregrina Cheese and its officers of their cGMP violations; NYSDAM has also assessed fines against the company.
Peregrina Cheese’s lack of effective measures to bring its food processing operations into compliance with the law poses a public health threat because of the potential that Listeria will be in the food processed by the company.
Listeriosis, the illness caused by Listeria monocytogenes, can be serious and sometimes cause fatal infections in young children, frail or older people, and others with weakened immune systems. Although healthy individuals may experience only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection in pregnant women can cause miscarriages and stillbirths.
No illnesses have been reported to date from Peregrina Cheese products. However, if individuals have eaten the products and are experiencing any of the symptoms listed above, they should contact their health care professional.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
Tuesday, July 7, 2009
New Public Health Regulation to Improve Egg Safety and Reduce Salmonella Illnesses
Media Inquiries: Susan Cruzan, 301-796-4675, susan.cruzan@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: New Public Health Regulation to Improve Egg Safety and Reduce Salmonella Illnesses
The U.S. Food and Drug Administration today announced a regulation expected to prevent each year 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella enteritidis.
The final rule requires preventive measures during the production of shell eggs in poultry houses and requires subsequent refrigeration during storage and transportation.
Egg-associated illness caused by Salmonella is a serious public health problem. Infected individuals may suffer mild to severe gastrointestinal illness, short term or chronic arthritis, or even death. Implementing the preventive measures would reduce the number of Salmonella enteritidis infections from eggs by nearly 60 percent.
“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today's action will prevent thousands of serious illnesses from Salmonella in eggs.”
Salmonella enteritidis can be found inside eggs that appear perfectly normal. If the eggs are eaten raw or undercooked, the bacterium can cause illness. Eggs in the shell become contaminated on the farm, primarily because of infection in the laying hens.
The rule requires that measures designed to prevent Salmonella enteritidis be adopted by virtually all egg producers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to ensure their safety.
Producers with at least 3,000 but fewer than 50,000 laying hens must comply within 36 months after the rule’s publication. Producers with 50,000 or more laying hens must be in compliance with the rule within 12 months after its publication in the Federal Register.
Under the rule, egg producers must:
Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria
Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment
Conduct testing in the poultry house for Salmonella enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an 8 week time period (4 tests at 2 week intervals); If any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use
Clean and disinfect poultry houses that have tested positive for Salmonella enteritidis
Refrigerate eggs at 45 degrees Fahrenheit temperature during storage and transportation no later than 36 hours after the eggs are laid.Egg producers whose eggs receive treatments such as pasteurization still must comply with the refrigeration requirements. Similarly, certain persons such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration requirements.
To ensure compliance, egg producers must maintain a written Salmonella enteritidis prevention plan and records documenting their compliance. Producers (except those who have less than 3000 hens or who sell all their eggs directly to consumers) also must register with the FDA. The FDA will develop guidance and enforcement plans to help egg producers comply with the rule.
The FDA estimated that the rule would provide $1.4 billion in annual public health benefits, at an annual cost of $81 million to the regulated industry, or less than 1 cent per dozen eggs produced in the United States.
During the 1990s, the FDA and the U.S. Department of Agriculture implemented a series of post-egg production safety efforts such as refrigeration requirements designed to inhibit the growth of bacteria that may be in an egg. While these steps limited the growth of bacteria, they did not prevent the initial contamination from occurring.
The new rule is part of a coordinated strategy between the FDA and the USDA’s Food Safety and Inspection Service (FSIS). The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.
In addition to the new safety measures being taken by industry, consumers can reduce their risk of foodborne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, make sure eggs in the carton are clean and not cracked, and cook eggs and foods containing eggs thoroughly.
For more information:http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm
Consumer Inquiries: 888-INFO-FDA
FDA: New Public Health Regulation to Improve Egg Safety and Reduce Salmonella Illnesses
The U.S. Food and Drug Administration today announced a regulation expected to prevent each year 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella enteritidis.
The final rule requires preventive measures during the production of shell eggs in poultry houses and requires subsequent refrigeration during storage and transportation.
Egg-associated illness caused by Salmonella is a serious public health problem. Infected individuals may suffer mild to severe gastrointestinal illness, short term or chronic arthritis, or even death. Implementing the preventive measures would reduce the number of Salmonella enteritidis infections from eggs by nearly 60 percent.
“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Today's action will prevent thousands of serious illnesses from Salmonella in eggs.”
Salmonella enteritidis can be found inside eggs that appear perfectly normal. If the eggs are eaten raw or undercooked, the bacterium can cause illness. Eggs in the shell become contaminated on the farm, primarily because of infection in the laying hens.
The rule requires that measures designed to prevent Salmonella enteritidis be adopted by virtually all egg producers with 3,000 or more laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to ensure their safety.
Producers with at least 3,000 but fewer than 50,000 laying hens must comply within 36 months after the rule’s publication. Producers with 50,000 or more laying hens must be in compliance with the rule within 12 months after its publication in the Federal Register.
Under the rule, egg producers must:
Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria
Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment
Conduct testing in the poultry house for Salmonella enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an 8 week time period (4 tests at 2 week intervals); If any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use
Clean and disinfect poultry houses that have tested positive for Salmonella enteritidis
Refrigerate eggs at 45 degrees Fahrenheit temperature during storage and transportation no later than 36 hours after the eggs are laid.Egg producers whose eggs receive treatments such as pasteurization still must comply with the refrigeration requirements. Similarly, certain persons such as distributors, packers, or truckers holding or transporting shell eggs also must comply with the refrigeration requirements.
To ensure compliance, egg producers must maintain a written Salmonella enteritidis prevention plan and records documenting their compliance. Producers (except those who have less than 3000 hens or who sell all their eggs directly to consumers) also must register with the FDA. The FDA will develop guidance and enforcement plans to help egg producers comply with the rule.
The FDA estimated that the rule would provide $1.4 billion in annual public health benefits, at an annual cost of $81 million to the regulated industry, or less than 1 cent per dozen eggs produced in the United States.
During the 1990s, the FDA and the U.S. Department of Agriculture implemented a series of post-egg production safety efforts such as refrigeration requirements designed to inhibit the growth of bacteria that may be in an egg. While these steps limited the growth of bacteria, they did not prevent the initial contamination from occurring.
The new rule is part of a coordinated strategy between the FDA and the USDA’s Food Safety and Inspection Service (FSIS). The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.
In addition to the new safety measures being taken by industry, consumers can reduce their risk of foodborne illness by following safe egg handling practices. The FDA reminds consumers to buy eggs that have been refrigerated, make sure eggs in the carton are clean and not cracked, and cook eggs and foods containing eggs thoroughly.
For more information:http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm
Nine Companies Penalized for Selling Children’s Products that Violated the Federal Lead Paint Ban
Nine Companies Penalized for Selling Children’s Products that Violated the Federal Lead Paint Ban
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that nine children’s product manufacturers, importers and sellers have agreed to pay more than $500,000 in civil penalties for violating the federal lead paint ban.
The penalties settle allegations that the firms knowingly manufactured, imported, or sold toys and other children’s articles with paint or other surface coatings that contained lead levels in violation of federal law. The settlements have been provisionally accepted by the Commission.
These products were recalled in 2007 and 2008, and include items such as toys, children’s metal jewelry, children’s pens, metal water bottles, pencil pouches, sunglasses and children’s
Halloween pails and baskets. Tests showed that paint or surface coatings on these children’s products contained lead in excess of 600 ppm, or 0.06 percent, by weight. One firm’s testing revealed that its products contained surface coatings with nearly 60 percent lead. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. Lead can be toxic if ingested by young children and can cause adverse health consequences.
CPSC has ordered the following firms to pay civil penalties to the federal government:
Cardinal Distributing Co. Inc., of Baltimore, Md., $100,000 Recall: #07-157
Dollar General Corp., of Goodlettsville, Tenn., $100,000 Recalls: 08-007, #08-068, #08-080
Family Dollar Stores Inc., of Matthews, N.C., $75,000 Recall: #08-051
Hobby Lobby Stores Inc., of Oklahoma City, Okla., $50,000 Recalls: #08-084, #08-229
First Learning Company Ltd., of Hong Kong, $50,000 Recalls: #08-141, #08-174
Michaels Stores Inc., of Irving, Texas, $45,000 Recall: #08-248
A&A Global Industries Inc., of Cockeysville, Md., $40,000 Recall: #07-144
Raymond Geddes & Co, of Baltimore, Md., $40,000 Recall: #08-096
Downeast Concepts Inc., of Yarmouth, Maine, $30,000 Recall: #08-231
In agreeing to settle the matters, the firms deny CPSC’s allegations that they knowingly violated the law
Cardinal Distributing Co. Inc. Jewelry
Dollar General Toy Cars
Family Dollar Halloween Pails
Hobby Lobby Halloween Baskets
First Learning Co. Ltd. Blocks Wagon
Michael’s Stores Writing Pens
A&A Global Industries Children’s Bracelets
Raymond Geddes Children’s Pencil Pouches
Downeast Concepts Metal Water Bottles
CPSC is still interested in receiving incident or injury reports that are either directly related to this product recall or involve a different hazard with the same product. Please tell us about it by visiting https://www.cpsc.gov/cgibin/incident.aspx
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that nine children’s product manufacturers, importers and sellers have agreed to pay more than $500,000 in civil penalties for violating the federal lead paint ban.
The penalties settle allegations that the firms knowingly manufactured, imported, or sold toys and other children’s articles with paint or other surface coatings that contained lead levels in violation of federal law. The settlements have been provisionally accepted by the Commission.
These products were recalled in 2007 and 2008, and include items such as toys, children’s metal jewelry, children’s pens, metal water bottles, pencil pouches, sunglasses and children’s
Halloween pails and baskets. Tests showed that paint or surface coatings on these children’s products contained lead in excess of 600 ppm, or 0.06 percent, by weight. One firm’s testing revealed that its products contained surface coatings with nearly 60 percent lead. In 1978, a federal ban was put in place which prohibited toys and other children’s articles from having more than 0.06 percent lead (by weight) in paints or surface coatings. Lead can be toxic if ingested by young children and can cause adverse health consequences.
CPSC has ordered the following firms to pay civil penalties to the federal government:
Cardinal Distributing Co. Inc., of Baltimore, Md., $100,000 Recall: #07-157
Dollar General Corp., of Goodlettsville, Tenn., $100,000 Recalls: 08-007, #08-068, #08-080
Family Dollar Stores Inc., of Matthews, N.C., $75,000 Recall: #08-051
Hobby Lobby Stores Inc., of Oklahoma City, Okla., $50,000 Recalls: #08-084, #08-229
First Learning Company Ltd., of Hong Kong, $50,000 Recalls: #08-141, #08-174
Michaels Stores Inc., of Irving, Texas, $45,000 Recall: #08-248
A&A Global Industries Inc., of Cockeysville, Md., $40,000 Recall: #07-144
Raymond Geddes & Co, of Baltimore, Md., $40,000 Recall: #08-096
Downeast Concepts Inc., of Yarmouth, Maine, $30,000 Recall: #08-231
In agreeing to settle the matters, the firms deny CPSC’s allegations that they knowingly violated the law
Cardinal Distributing Co. Inc. Jewelry
Dollar General Toy Cars
Family Dollar Halloween Pails
Hobby Lobby Halloween Baskets
First Learning Co. Ltd. Blocks Wagon
Michael’s Stores Writing Pens
A&A Global Industries Children’s Bracelets
Raymond Geddes Children’s Pencil Pouches
Downeast Concepts Metal Water Bottles
CPSC is still interested in receiving incident or injury reports that are either directly related to this product recall or involve a different hazard with the same product. Please tell us about it by visiting https://www.cpsc.gov/cgibin/incident.aspx
Monday, July 6, 2009
The Government of Canada Reminds Canadians of the Safe Handling of Fresh Produce
The Government of Canada Reminds Canadians of the Safe Handling of Fresh Produce
2009-113
OTTAWA - Health Canada and the Canadian Food Inspection Agency would like to remind Canadians of the importance of safe handling of fresh produce to reduce the risk of foodborne illness.
Fresh fruits and vegetables do not naturally contain microorganisms (i.e., bacteria, parasites or viruses) that can make you sick. However, fresh produce can become contaminated while in the field or through improper handling, storage or transportation during or after harvest.
Eating Well with Canada's Food Guide recommends Canadians eat a diet rich in a variety of fruits and vegetables as part of a healthy diet. But, as with any food, it is important that fresh produce be handled and stored properly to reduce the chances of becoming sick. It is estimated that approximately 11 million Canadians suffer from foodborne illness every year.
You can reduce the risk of foodborne illness by following these food safety tips:
Separate: Fresh produce can become contaminated when they come into contact with raw meat, poultry, seafood and their juices. Make sure to keep your fresh fruits and vegetables separate from raw meat in the grocery cart at the store and also in your refrigerator, cutting boards and counters at home.
Clean: You should wash your fresh fruits and vegetables gently under cool running water. Do not soak your fresh fruits and vegetables in a sink full of water as the sink can harbour bacteria that can be transferred to the fresh produce. It is not necessary to use anything other than water to wash your produce. Washing with water is as effective as using produce washes.
Chill: Store your fresh fruits and vegetables in the refrigerator at 4ºC (40ºF) or below. All cut fruits and vegetables should be refrigerated and should not be kept out at room temperature for longer than 2 hours.
For more information on Fresh Produce Safety, please visit Health Canada's website.
2009-113
OTTAWA - Health Canada and the Canadian Food Inspection Agency would like to remind Canadians of the importance of safe handling of fresh produce to reduce the risk of foodborne illness.
Fresh fruits and vegetables do not naturally contain microorganisms (i.e., bacteria, parasites or viruses) that can make you sick. However, fresh produce can become contaminated while in the field or through improper handling, storage or transportation during or after harvest.
Eating Well with Canada's Food Guide recommends Canadians eat a diet rich in a variety of fruits and vegetables as part of a healthy diet. But, as with any food, it is important that fresh produce be handled and stored properly to reduce the chances of becoming sick. It is estimated that approximately 11 million Canadians suffer from foodborne illness every year.
You can reduce the risk of foodborne illness by following these food safety tips:
Separate: Fresh produce can become contaminated when they come into contact with raw meat, poultry, seafood and their juices. Make sure to keep your fresh fruits and vegetables separate from raw meat in the grocery cart at the store and also in your refrigerator, cutting boards and counters at home.
Clean: You should wash your fresh fruits and vegetables gently under cool running water. Do not soak your fresh fruits and vegetables in a sink full of water as the sink can harbour bacteria that can be transferred to the fresh produce. It is not necessary to use anything other than water to wash your produce. Washing with water is as effective as using produce washes.
Chill: Store your fresh fruits and vegetables in the refrigerator at 4ºC (40ºF) or below. All cut fruits and vegetables should be refrigerated and should not be kept out at room temperature for longer than 2 hours.
For more information on Fresh Produce Safety, please visit Health Canada's website.
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