Tuesday, April 28, 2009
Does Anyone Watch 24?
I have now come across two references on websites to Jack Bauer on 24 being infected with mad cow disease. I would have thought there would be more stuff on the internet about it, but I am curious. Any 24 watchers out there in the know? And if this is the case, is anything about it even remotely accurate?
Thursday, April 23, 2009
Feed Ban Rules Implemented -
Below is a press release issued yesterday by the FDA. Thanks to everyone for submitting comments. It's nice to know sometimes they listen to us! Now, let's just hope they don't repeatedly extend the compliance date.
April 22, 2009
FDA Announces Confirmation of the Effective Date of the BSE Final Rule
The Food and Drug Administration today announced that the final rule entitled ‘‘Substances Prohibited From Use in Animal Food or Feed,’’ will become effective on April 27, 2009. However, to allow renderers additional time to comply with the new requirements, the Agency has established a compliance date of October 26, 2009. The additional 6 months will provide time for those affected to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule. FDA is encouraging affected parties who are able to begin complying with the rule to do so as soon as possible.
In the April 9, 2009, Federal Register FDA proposed to delay the effective date of the final rule for 60 days and provided a period of 7 days for public comment. The agency received over 400 comments from state and national cattle producer organizations, individual cattle producers, renderers, meat processors, dairy organizations, State agriculture agencies, and consumers.
Many of the comments indicated that certain entities were not adequately prepared to comply with the final rule and that adequate alternative carcass disposal methods had not been developed. However, a significant number of comments received opposed delaying the effective date of the final rule due to public and animal health concerns.
In consideration of all comments received, FDA believes the most appropriate action is to confirm the April 27, 2009, effective date, and establish a compliance date of October 26, 2009, for those who need additional time to address compliance and implementation concerns.
FDA will conduct outreach to affected stakeholders to help them comply with the rule. The Agency will hold a 50-state call to discuss the disposal issues in various states or regions and will engage others affected by the rule to assist as much as possible with meeting challenging carcass disposal issues by the October 26, 2009 compliance date. FDA also plans on finalizing the Small Entities Compliance Guide #195 for Renderers to provide additional information specific to the concerns of the rendering industry.Questions may be directed to Burt Pritchett, Center for Veterinary Medicine (HFV-22), FDA, 7519 Standish Place, Rockville, MD 20855, 240-453-6860, burt.pritchett@fda.hhs.gov.
For additional information, please see http://www.federalregister.gov/OFRUpload/OFRData/2009-09466_PI.pdf and http://www.fda.gov/cvm/bsetoc.html.
April 22, 2009
FDA Announces Confirmation of the Effective Date of the BSE Final Rule
The Food and Drug Administration today announced that the final rule entitled ‘‘Substances Prohibited From Use in Animal Food or Feed,’’ will become effective on April 27, 2009. However, to allow renderers additional time to comply with the new requirements, the Agency has established a compliance date of October 26, 2009. The additional 6 months will provide time for those affected to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule. FDA is encouraging affected parties who are able to begin complying with the rule to do so as soon as possible.
In the April 9, 2009, Federal Register FDA proposed to delay the effective date of the final rule for 60 days and provided a period of 7 days for public comment. The agency received over 400 comments from state and national cattle producer organizations, individual cattle producers, renderers, meat processors, dairy organizations, State agriculture agencies, and consumers.
Many of the comments indicated that certain entities were not adequately prepared to comply with the final rule and that adequate alternative carcass disposal methods had not been developed. However, a significant number of comments received opposed delaying the effective date of the final rule due to public and animal health concerns.
In consideration of all comments received, FDA believes the most appropriate action is to confirm the April 27, 2009, effective date, and establish a compliance date of October 26, 2009, for those who need additional time to address compliance and implementation concerns.
FDA will conduct outreach to affected stakeholders to help them comply with the rule. The Agency will hold a 50-state call to discuss the disposal issues in various states or regions and will engage others affected by the rule to assist as much as possible with meeting challenging carcass disposal issues by the October 26, 2009 compliance date. FDA also plans on finalizing the Small Entities Compliance Guide #195 for Renderers to provide additional information specific to the concerns of the rendering industry.Questions may be directed to Burt Pritchett, Center for Veterinary Medicine (HFV-22), FDA, 7519 Standish Place, Rockville, MD 20855, 240-453-6860, burt.pritchett@fda.hhs.gov.
For additional information, please see http://www.federalregister.gov/OFRUpload/OFRData/2009-09466_PI.pdf and http://www.fda.gov/cvm/bsetoc.html.
Friday, April 10, 2009
FDA Food Ban
The CJD Foundation sent out an email to its members yesterday regarding a comment period on proposed delays to the feed ban set to go into effect later this month. I've pasted the email below in its entirety. Please help out by sending the attached letter in, or writing a personal one of your own. And thanks to the CJD Foundation for getting the word out about this!
The CJD Foundation has issued this information in partnership with R-CALF (This is not a News Release)
To: The CJD Foundation Family Members and Friends and R-CALF USA Members and Affiliates
From: Florence Kranitz, President, the CJD Foundation and Bill Bullard, R-CALF USA CEO
Date: April 9, 2009
Subject: FDA Comment Period on Feed Ban Starts Today – Ends April 16 Please consider commenting on FDA’s plan to delay the scheduled April 27, 2009, implementation of the BSE feed ban needed to address the heightened risk of BSE we already have assumed by allowing high-risk Canadian cattle into the United States. Below is a short background, instructions on how to submit comments, and a sample letter you can use to submit your comments. We need thousands of comments on this issue! Background: Our April 7, Member Alert provided more background on this issue but today the U.S. Food and Drug Administration (FDA) has opened a 7-day public comment period to solicit public comments on whether the FDA should delay implementation of its upgraded bovine spongiform encephalopathy (BSE) feed ban. The U.S. Department of Agriculture (USDA) and the FDA have purposely positioned consumers and the cattle industry between a rock and a hard place. There is no doubt that cattle producers who rely on rendering services to pick up deadstock will experience a hardship if the FDA’s new BSE feed ban rule takes effect. The government is banking on cattle producers to support this last minute delay for this very reason. But, the government has purposely backed our cattle industry into a corner and we should not quietly allow this kind of manipulation. The government, through the USDA, has exposed U.S. consumers and the U.S. cattle herd to an unacceptable risk of BSE by allowing Canada’s highest-risk cattle – cattle over 30 months (OTM) of age – to freely enter the U.S. food supply, feed supply, and cattle herd. USDA should not have allowed these higher-risk cattle into the U.S. until after it determined if it was feasible to assume the additional costs necessary to mitigate this increased risk – the cost of upgrading the U.S. feed ban. But this is exactly what has happened and this is what we are now faced with. We have to demand that our government do what is right by acting immediately to protect the health and safety of all U.S consumers and cattle herds. They must eliminate the source of the higher BSE risk by closing the border to OTM Canadian cattle and by immediately implementing the upgraded feed ban needed to minimize this higher risk. There are no responsible alternatives.
Below is a sample letter you can use to submit your comments to the FDA. We need thousands of comments submitted within the next 7 days, so please circulate this Alert as widely as possible and encourage as many people as possible to submit comments as well.
How to submit your written comments (Deadline April 16, 2009):
1. Go to http://www.regulations.gov/
2. Type in FDA-2002-N-0031
3. Click on box that states: “Select to find documents accepting comments or submissions.”
4. Click on: Go>>
5. Click on the balloon shaped icon that states “Send a Comment or Submission.”
6. Follow the instructions on the “Public Comment and Submission Form.”
Sample Comment Letter for Your Use (You are free to use all or part of this letter):
April 9, 2009
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061Rockville, MD 20852
Re: Docket Number: FDA-2002-N-0031 (formerly Docket No. 2002N-0273)
Dear Administrator,
As the family member of a loved one who has died of a Creutzfeldt-Jakob Disease (CJD), one form of which can be acquired by ingesting BSE contaminated beef, I want to express my outrage at the recent announcement of the U.S. Food and Drug Administration’s (FDA) delay of its April 17, 2009 scheduled implementation of the final rule titled “Substances Prohibited from Use in Animal Food or Feed,” commonly referred to as the 2008 BSE final rule. They have made this announcement with full knowledge that the U.S. Department of Agriculture (USDA) continues to subject U.S. consumers and the U.S. cattle herd to a heighted risk of bovine spongiform encephalopathy (BSE) from imports of live Canadian cattle, particularly imports of Canadian cattle over 30 months (OTM) of age.
In Canada the disease occurrence is between three cases per million to eight cases per million cattle. The U.S. Centers for Disease Control and Prevention (CDC) states the level of BSE prevalence in the Canadian cattle herd is 18-fold to 48-fold higher than the prevalence estimated in the U.S. cattle herd. Just in 2008, nearly 1.6 million Canadian cattle were imported into the United States. By delaying the implementation of the Feed Ban the FDA risks yet another break in an already severely compromised food safety firewall.
When USDA reopened the U.S. border in 2007 to Canada’s highest-risk cattle population – OTM cattle – its risk modeling based on a Canadian BSE prevalence of fewer than 4 cases per million predicted that the U.S. would import over 100 head of BSE-infected cattle from Canada over the next 20 years. In addition, the risk modeling showed that human exposure to BSE would increase. However, as the CDC explained, the BSE prevalence in Canada could well be 8 cases per million, meaning that USDA likely has grossly underestimated the risk of introducing BSE-infected cattle into the U.S. as a result of allowing OTM Canadian cattle imports. Canada already has detected 16 native cases of BSE in its OTM cattle herd, 10 of which were born after the 1997 feed ban. The most recent of these cases was detected just last November. Nine of Canada’s BSE-infected cattle met USDA’s age requirements to be exported to the United States, as they were born after March 1, 1999, the date after which USDA erroneously claims BSE-infectivity was no longer circulating in Canada.
The current U.S. feed ban implemented in 1997 is comparable to the initial Canadian feed ban also implemented in 1997. Canada’s feed ban proved ineffective at preventing the spread of BSE in Canada. Despite the repeated urging of international scientists, Canada resisted any upgrades to its feed ban until after it detected multiple BSE cases in cattle born years after its 1997 feed ban. Canada’s July 2007 upgraded feed ban now protects Canadian consumers against the spread of BSE from Canadian cattle by closing known transmission routes, including cross-contamination and inadvertent feeding of contaminated cattle parts. It is unthinkable that the FDA would not afford U.S. consumers the same level of protection against these same Canadian cattle that are imported into the United States.
The FDA cannot legitimately argue that its current feed ban implemented in 1997, which is nearly identical to Canada’s original feed ban also implemented in 1997, is any more effective at mitigating Canada’s heightened BSE risk within U.S. borders than it was in mitigating Canada’s heightened BSE risk in Canada. Nor can FDA ignore the scientific evidence that overwhelmingly shows that the current U.S. feed ban is insufficient to mitigate the heightened BSE risk associated with OTM cattle imported from Canada. These higher-risk OTM Canadian cattle are entering the U.S. at the rate of several thousand per week, are being commingled in the U.S. cattle herd where some would be expected to die, and are entering both the U.S. food system as well as the U.S. animal feed system. The U.S. already is accepting Canada’s higher BSE risk without the protections necessary to mitigate that higher risk.
The FDA cannot bury its head in the sand and pretend the upgraded feed ban contained in the 2008 BSE final rule is not urgently needed to mitigate the increased BSE risk associated with the importation of millions of Canadian cattle. In fact, the FDA already has failed to timely implement an upgraded feed ban, which should have been implemented before USDA began to expose U.S. consumers and the U.S. cattle herd to Canada’s heightened BSE risk.
The FDA has an absolute responsibility to protect the health and safety of U.S. consumers and the U.S. cattle herd against this foreign animal disease which is always 100% fatal, and has been known to cross the species barrier infecting humans with variant Creutzfeldt-Jakob Disease (vCJD), the human form of BSE. We need only look to the United Kingdom’s recent tragic experience when it was discovered that BSE had crossed the species barrier to humans. Thus far this preventable disease has caused the deaths of 168 young adults. The long incubation period (which can be up to 40 years), means that tragically, there could be many more cases in the future. The FDA must break away from the manipulative actions by corporate-controlled, self-serving trade associations that have caused both FDA and USDA to endanger the health and safety of U.S. consumers and the U.S. cattle herd by exposing them to an unnecessary and avoidable risk of BSE.
The USDA must immediately eliminate the source of this heightened BSE risk by prohibiting the importation of OTM Canadian cattle, and the FDA must immediately implement the 2008 BSE final rule to mitigate this heightened risk. There are no responsible alternatives.
Sincerely,
The CJD Foundation has issued this information in partnership with R-CALF (This is not a News Release)
To: The CJD Foundation Family Members and Friends and R-CALF USA Members and Affiliates
From: Florence Kranitz, President, the CJD Foundation and Bill Bullard, R-CALF USA CEO
Date: April 9, 2009
Subject: FDA Comment Period on Feed Ban Starts Today – Ends April 16 Please consider commenting on FDA’s plan to delay the scheduled April 27, 2009, implementation of the BSE feed ban needed to address the heightened risk of BSE we already have assumed by allowing high-risk Canadian cattle into the United States. Below is a short background, instructions on how to submit comments, and a sample letter you can use to submit your comments. We need thousands of comments on this issue! Background: Our April 7, Member Alert provided more background on this issue but today the U.S. Food and Drug Administration (FDA) has opened a 7-day public comment period to solicit public comments on whether the FDA should delay implementation of its upgraded bovine spongiform encephalopathy (BSE) feed ban. The U.S. Department of Agriculture (USDA) and the FDA have purposely positioned consumers and the cattle industry between a rock and a hard place. There is no doubt that cattle producers who rely on rendering services to pick up deadstock will experience a hardship if the FDA’s new BSE feed ban rule takes effect. The government is banking on cattle producers to support this last minute delay for this very reason. But, the government has purposely backed our cattle industry into a corner and we should not quietly allow this kind of manipulation. The government, through the USDA, has exposed U.S. consumers and the U.S. cattle herd to an unacceptable risk of BSE by allowing Canada’s highest-risk cattle – cattle over 30 months (OTM) of age – to freely enter the U.S. food supply, feed supply, and cattle herd. USDA should not have allowed these higher-risk cattle into the U.S. until after it determined if it was feasible to assume the additional costs necessary to mitigate this increased risk – the cost of upgrading the U.S. feed ban. But this is exactly what has happened and this is what we are now faced with. We have to demand that our government do what is right by acting immediately to protect the health and safety of all U.S consumers and cattle herds. They must eliminate the source of the higher BSE risk by closing the border to OTM Canadian cattle and by immediately implementing the upgraded feed ban needed to minimize this higher risk. There are no responsible alternatives.
Below is a sample letter you can use to submit your comments to the FDA. We need thousands of comments submitted within the next 7 days, so please circulate this Alert as widely as possible and encourage as many people as possible to submit comments as well.
How to submit your written comments (Deadline April 16, 2009):
1. Go to http://www.regulations.gov/
2. Type in FDA-2002-N-0031
3. Click on box that states: “Select to find documents accepting comments or submissions.”
4. Click on: Go>>
5. Click on the balloon shaped icon that states “Send a Comment or Submission.”
6. Follow the instructions on the “Public Comment and Submission Form.”
Sample Comment Letter for Your Use (You are free to use all or part of this letter):
April 9, 2009
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061Rockville, MD 20852
Re: Docket Number: FDA-2002-N-0031 (formerly Docket No. 2002N-0273)
Dear Administrator,
As the family member of a loved one who has died of a Creutzfeldt-Jakob Disease (CJD), one form of which can be acquired by ingesting BSE contaminated beef, I want to express my outrage at the recent announcement of the U.S. Food and Drug Administration’s (FDA) delay of its April 17, 2009 scheduled implementation of the final rule titled “Substances Prohibited from Use in Animal Food or Feed,” commonly referred to as the 2008 BSE final rule. They have made this announcement with full knowledge that the U.S. Department of Agriculture (USDA) continues to subject U.S. consumers and the U.S. cattle herd to a heighted risk of bovine spongiform encephalopathy (BSE) from imports of live Canadian cattle, particularly imports of Canadian cattle over 30 months (OTM) of age.
In Canada the disease occurrence is between three cases per million to eight cases per million cattle. The U.S. Centers for Disease Control and Prevention (CDC) states the level of BSE prevalence in the Canadian cattle herd is 18-fold to 48-fold higher than the prevalence estimated in the U.S. cattle herd. Just in 2008, nearly 1.6 million Canadian cattle were imported into the United States. By delaying the implementation of the Feed Ban the FDA risks yet another break in an already severely compromised food safety firewall.
When USDA reopened the U.S. border in 2007 to Canada’s highest-risk cattle population – OTM cattle – its risk modeling based on a Canadian BSE prevalence of fewer than 4 cases per million predicted that the U.S. would import over 100 head of BSE-infected cattle from Canada over the next 20 years. In addition, the risk modeling showed that human exposure to BSE would increase. However, as the CDC explained, the BSE prevalence in Canada could well be 8 cases per million, meaning that USDA likely has grossly underestimated the risk of introducing BSE-infected cattle into the U.S. as a result of allowing OTM Canadian cattle imports. Canada already has detected 16 native cases of BSE in its OTM cattle herd, 10 of which were born after the 1997 feed ban. The most recent of these cases was detected just last November. Nine of Canada’s BSE-infected cattle met USDA’s age requirements to be exported to the United States, as they were born after March 1, 1999, the date after which USDA erroneously claims BSE-infectivity was no longer circulating in Canada.
The current U.S. feed ban implemented in 1997 is comparable to the initial Canadian feed ban also implemented in 1997. Canada’s feed ban proved ineffective at preventing the spread of BSE in Canada. Despite the repeated urging of international scientists, Canada resisted any upgrades to its feed ban until after it detected multiple BSE cases in cattle born years after its 1997 feed ban. Canada’s July 2007 upgraded feed ban now protects Canadian consumers against the spread of BSE from Canadian cattle by closing known transmission routes, including cross-contamination and inadvertent feeding of contaminated cattle parts. It is unthinkable that the FDA would not afford U.S. consumers the same level of protection against these same Canadian cattle that are imported into the United States.
The FDA cannot legitimately argue that its current feed ban implemented in 1997, which is nearly identical to Canada’s original feed ban also implemented in 1997, is any more effective at mitigating Canada’s heightened BSE risk within U.S. borders than it was in mitigating Canada’s heightened BSE risk in Canada. Nor can FDA ignore the scientific evidence that overwhelmingly shows that the current U.S. feed ban is insufficient to mitigate the heightened BSE risk associated with OTM cattle imported from Canada. These higher-risk OTM Canadian cattle are entering the U.S. at the rate of several thousand per week, are being commingled in the U.S. cattle herd where some would be expected to die, and are entering both the U.S. food system as well as the U.S. animal feed system. The U.S. already is accepting Canada’s higher BSE risk without the protections necessary to mitigate that higher risk.
The FDA cannot bury its head in the sand and pretend the upgraded feed ban contained in the 2008 BSE final rule is not urgently needed to mitigate the increased BSE risk associated with the importation of millions of Canadian cattle. In fact, the FDA already has failed to timely implement an upgraded feed ban, which should have been implemented before USDA began to expose U.S. consumers and the U.S. cattle herd to Canada’s heightened BSE risk.
The FDA has an absolute responsibility to protect the health and safety of U.S. consumers and the U.S. cattle herd against this foreign animal disease which is always 100% fatal, and has been known to cross the species barrier infecting humans with variant Creutzfeldt-Jakob Disease (vCJD), the human form of BSE. We need only look to the United Kingdom’s recent tragic experience when it was discovered that BSE had crossed the species barrier to humans. Thus far this preventable disease has caused the deaths of 168 young adults. The long incubation period (which can be up to 40 years), means that tragically, there could be many more cases in the future. The FDA must break away from the manipulative actions by corporate-controlled, self-serving trade associations that have caused both FDA and USDA to endanger the health and safety of U.S. consumers and the U.S. cattle herd by exposing them to an unnecessary and avoidable risk of BSE.
The USDA must immediately eliminate the source of this heightened BSE risk by prohibiting the importation of OTM Canadian cattle, and the FDA must immediately implement the 2008 BSE final rule to mitigate this heightened risk. There are no responsible alternatives.
Sincerely,
Monday, April 6, 2009
Slowly But Surely
It seems like I've been doing a little bit of everything the past week! I met with Wendy, a good friend of mine who is going to design the website. I should have the design in the next week or so, and then it is just up to me to get the information written up for it. We have a scheduled launch date of May 1. Once the site is up and running, I plan to move the blog over to the website so watch for a notice of the switch!
I talked to the Virginia Department of Health, trying to get some more information about the state's reporting requirements. I am a Virginia resident, so I figured it was probably best to start there. From what I have gathered, state reporting requirements only require reporting to the state's health department, not the CDC. Given this, I think it is very important to start working on national reporting requirements. I am not sure the best way to go about this yet, but it is something I will be talking to people about to figure out how to get it done.
I also talked to the delegate in the Virginia House of Delegates that I used to work for. He was very helpful in giving me some suggestions, and also told me I could come to him if I needed legislation introduced. I'm very glad to know I have someone I can go to for advice - and help - if I need it!
There is also an opportunity that may be coming up where I can start to get the word out more - not only about starting my organization, but about CJD and prion diseases in general. I will post more on this later if it ends up working out.
Finally, I will direct you to an interesting article I came across regarding prions in yeast. It seems it may open up some new avenues for research, and assist in determining why prions have both the normal and misfolded forms.
I talked to the Virginia Department of Health, trying to get some more information about the state's reporting requirements. I am a Virginia resident, so I figured it was probably best to start there. From what I have gathered, state reporting requirements only require reporting to the state's health department, not the CDC. Given this, I think it is very important to start working on national reporting requirements. I am not sure the best way to go about this yet, but it is something I will be talking to people about to figure out how to get it done.
I also talked to the delegate in the Virginia House of Delegates that I used to work for. He was very helpful in giving me some suggestions, and also told me I could come to him if I needed legislation introduced. I'm very glad to know I have someone I can go to for advice - and help - if I need it!
There is also an opportunity that may be coming up where I can start to get the word out more - not only about starting my organization, but about CJD and prion diseases in general. I will post more on this later if it ends up working out.
Finally, I will direct you to an interesting article I came across regarding prions in yeast. It seems it may open up some new avenues for research, and assist in determining why prions have both the normal and misfolded forms.
Subscribe to:
Posts (Atom)