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From: TSS ()
Subject: Changes proposed to animal by-products law (including TSEs in your cosmetics)
Date: November 8, 2005 at 6:47 pm PST

Changes proposed to animal by-products law

By Ahmed ElAmin


26/10/2005 - A new report on animal by-products (ABPs) outlines additional proposed regulations governing how processors may dispose of or sell the left over materials produced by their plants.

ABPs are animal carcasses, parts of carcasses and other products of animal origin, such as milk, which are not intended for human consumption.

The wide ranging proposals include allowing the use of additional disposal methods and techniques, giving food processors more flexibility in the use of third party contractors.

They also seek to clarify and simplify the rules in a bid to ensure their application is consistent throughout the EU.

The EU's ABP regulation, applicable since 1 May 2003, was adopted in response to various food-borne crises, include BSE and foot-and-mouth diseases. The regulation not only prohibited the feeding of animal parts to livestock but also laid down the health rules for the handling, processing, use and disposal of ABPs.

ABP's are a regular product of the livestock and food industries and include animals which die on farm, surplus or waste material from slaughterhouses, and a range of surplus or rejected foodstuffs and leftovers, whether cooked or uncooked.

Some of these animal by- products are sold or used by food processors to make animal proteins, such as meat and bone meal, fats, gelatine, collagen, pet-food. They are also used to make products such as glue, leathers, soaps, fertilisers, cosmetics. medicinal products, medical devices such as laboratory reagents, soil improvers, oleo-chemical products and photographic paper coating.

The 2003 regulation prohibits the disposal of animal by-products to landfill. Instead they must be treated at an approved rendering, incinerator, biogas or composting plant.

In its report the Commission finds that member states' compliance with the EU rules has been generally "satisfactory". However changes are needed to some aspects of the regulation in order to clarify its scope, make measures more proportionate to the risks, and remove unnecessary obstacles to the competitiveness of industry, the Commission stated yesterday.

"Some requirements may be disproportionate when it comes to very low risk products, for example processed ingredients used in cosmetics, while there is a need to insert new products under the different risk categories," the Commission stated. "In addition, there are areas where there is uncertainty about the scope, the requirements of the regulation or possible duplication with other legislation, and clarification is needed."

The Commission is seeking comments on the report and plans to submit a number of proposals for amendments to the regulation by the start of 2007.

The EU's food sector produces about 16 million tonnes of materials of animal origin not intended for human consumption, the bulk of which derive from healthy animals.

Some of these materials are then transformed in a variety of products used in animal feed, cosmetics, medicinal products, medical devices such as laboratory reagents, fertilisers, soil improver, oleo-chemical products, photographic paper coating.

More and more materials are being imported from third countries for similar uses into the EU, the Commission reported.

The original regulation was brought in because ABPs in animal feed can spread BSE and other animal diseases or spread chemical contaminants such as dioxins. ABPs can also pose a threat to animal and human health via the environment, if not properly disposed of.

Under the regulation, only materials derived from animal declared fit for human consumption following veterinary inspection may be used for the production of feeds.

It also bans intra-species recycling, so-called "cannibalism". It sets out clear rules on what must and may be done with the excluded animal materials, imposing strict identification and traceability system requiring certain products such as meat and bone meal and fats destined for destruction to be permanently marked to avoid possible fraud and risk of diversion of unauthorised products into food and feed.

It lays down the requirements for the importation and transit from non-Member countries of certain animal by-products and derived products.

The Commission proposes to amend the definitions for ABPs not yet covered, stating that there is a need to clarify the definition of certain ABPs so as to ensure a common application of the regulation in member countries.

One example is the scope of the definition for “former foodstuffs” products of animal origin or containing them, which are no longer intended for human consumption for different reasons.

The Commission also wants to clarify EU veterinary and waste legislation applicable to ABPs.

Member states and operators have lobbied the EU on this issue saying they want to avoid duplication and any resulting unnecessary burden due to the concurrent application to ABPs of community veterinary and waste legislation.

EU veterinary procedures fall under the responsibility of health and consumer directorate, while waste legislation falls under the environmental directorate.

"Guidance has been issued which seeks to clarify the relationship between the two sets of controls," the Commission stated. "However, more legal clarity is needed."

The Commission proposes five alternatives methods for the processing, use and disposal of ABPs. The Commission also wants to clarify the relationship between different regulations relating to waste shipments.

Due to complaints about the strictness of the regulation relating to composting and biogas plants and heat treatment process for manure, the Commission proposes to allow for alternative transformation parameters, such as time, temperature and microbiological validation agents.

An amendment to a regulation this year allowing the direct feeding to farmed animals of dairy products produced to food standards also needs to be amended to meet food safety requirements, the Commission stated.

The ABPs regulation does not currently apply to finished products, such as cosmetic products, medicinal products, medical devices or in-vitro diagnostics.

However, the ABPs regulation has an important regulatory impact on these sectors. The Commission wants to simplify the application of the regulation to those sectors.

http://www.meatprocess.com/news/ng.asp?n=63481-animal-by-products-waste-bse


Publicerat 6 november 2005 04:01

Döda djur kan tillåtas i kosmetika

Organ från självdöda djur kan åter bli tillåtet som råvara i kosmetika i EU.

För några år sedan blev kadaver efter självdöda djur förbjudna som råvara med hänvisning till risken för spridning av en mänsklig variant av galna kosjukan, en hjärnsjukdom som påminner om Creutzfeldt Jakobs sjuka. Förbudet gäller såväl livsmedel som djurfoder sedan slutet av 1990-talet och i kosmetika efter en rapport år 2000.

EU-kommissionen föreslår undantag från förbudet för kosmetika, skriver Svenska Dagbladet.

Förbudet kom sedan det blivit känt att organ som bräss, hjärnsubstans, mjälte och moderkaka var råvaror i kostsamma anti-rynkkrämer.

Skälet till förbuden är oro för att prioner, en sorts protein som anses vålla galna kosjukan, kan spridas via kadaver.

- Jag vet att kommissionen är utsatt för ett mycket hårt tryck från industrin. Samtidigt får det brittiska ordförandeskapet skarpa påtryckningar från USA, säger förra EU-parlamentarikern Marit Paulsen till SvD.

Paulsen var med om att driva genom förbudet mot kadaverdelar i bland annat kosmetika och djurfoder.

EU-kommissionen överväger att blåsa faran över för galna kosjukan. De miljardbelopp provtagning kostar vill den använda till annat.


STOCKHOLM TT

http://www.svd.se/dynamiskt/utrikes/did_10949978.asp

USA



January 14, 2004; Updated July 9, 2004, June 30, 2005 and September 14, 2005

Commonly Asked Questions About BSE in Products Regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN)
In light of the June 24, 2005 announcement of the second case of BSE in a cow in the United States, CFSAN has reviewed the products it regulates to ensure their safety.
What is "Mad Cow Disease" (Bovine Spongiform Encephalopathy/BSE)?
Mad Cow Disease is the commonly used name for Bovine Spongiform Encephalopathy (BSE), a slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. Since 1990, the U.S. Department of Agriculture (USDA) has conducted aggressive surveillance of the highest risk cattle going to slaughter in the United States.

What causes BSE?
The exact cause of BSE is not known but it is generally accepted by the scientific community that the likely cause is infectious forms of a type of protein, prions, normally found in animals cause BSE. In cattle with BSE, these abnormal prions initially occur in the small intestines and tonsils, and are found in central nervous tissues, such as the brain and spinal cord, and other tissues of infected animals experiencing later stages of the disease.

Was a second case of BSE identified in the U.S. in June 2005?
Yes, the USDA surveillance program identified the second BSE case in the U.S. This cow was originally identified in November 2004. Results from this animal were inconclusive in screening tests, but negative in confirmatory immunohistochemical tests. USDA recently conducted an additional confirmatory test, Western Blot, and the results were positive for BSE. USDA sent the samples to the Weybridge, UK lab where BSE was confirmed. An epidemiological investigation to trace the origins of the cow is underway. USDA confirms that the cow was born before the U.S. instituted its ban on the use of most mammalian protein in feed for ruminant animals-believed to be the most critical protective measure in preventing the spread of BSE among cattle.

Did meat and meat products from the June 2005 cow enter the food supply?
No, the cow was presented at slaughter as non-ambulatory (a downer). Therefore, in accordance with BSE regulations established by USDA and FDA the material from the animal did not enter the human food supply.

Was a case of BSE identified in the U.S. in December 2003?
Yes, the USDA surveillance program identified the first BSE case in the U.S. in a dairy cow in Washington State. The cow was bought from a farm in Canada.

Did meat and meat products from the 2003 BSE cow enter the food supply?
As soon as the BSE case was identified, both USDA and FDA activated their BSE Emergency Response Plans, and USDA immediately recalled the meat. Meat that did enter the food supply was quickly traced and was removed from the marketplace. Moreover, all the organs in which infectious prions occur were removed at slaughter and did not enter the food supply. Consumers should feel very confident that the system of multiple firewalls maintained by Federal agencies protects them from possible exposure to BSE. In addition, we believe it is important for consumers to also understand that scientific research indicates that muscle meat is not a source of infectious prions.

Will there be additional cases?
In 1998, USDA commissioned the Harvard Center for Risk Analysis to conduct an analysis and evaluation of the U.S. regulatory measures to prevent the spread of BSE in the U.S. and to reduce the potential exposure of U.S. consumers to BSE. The Harvard study concluded that, if introduced, due to the preventive measures currently in place in the U.S., BSE is extremely unlikely to become established in the United States.

FDA and other Federal agencies have been vigilant in strengthening protective measures to reduce the U.S. consumer's risk of exposure to BSE-contaminated food and cosmetic products. Since 1989, USDA has banned imports of live ruminants, such as cattle, sheep and goats, and most products from these animals from countries known to have BSE. Subsequently, USDA expanded this ban to include both countries with BSE and countries at risk for BSE. In 1997, FDA prohibited, with some exceptions, the use of protein derived from mammalian tissues in animal feed intended for cows and other ruminants. See the FDA/CVM website at www.fda.gov/cvm for information on the "ruminant feed ban."

On Jan. 8, 2004, the USDA's Food Safety and Inspection Service issued new rules to enhance safeguards against BSE. Details on these rules may be found at USDA's website, www.usda.gov. Also in 2004, FDA issued a rule that prohibits the use of certain cattle material, because of the risk of BSE, in human food and cosmetics.

Does BSE affect people?
There is a disease similar to BSE called Creutzfeldt-Jacob Disease (CJD) that is found in people. A variant form of CJD (vCJD) is believed to be caused by eating contaminated beef products from BSE-affected cattle. To date, there have been 155 confirmed and probable cases of vCJD worldwide among the hundreds of thousands of people that may have consumed BSE-contaminated beef products. The one reported case of vCJD in the United States was in a young woman who contracted the disease while residing in the UK and developed symptoms after moving to the U.S.

What measures are being taken to ensure food safety in the U.S. from BSE?
Since 1989, the FDA and other federal agencies have had ongoing regulatory measures in place to prevent BSE contamination of U.S. food and food products. Following the identification in a Washington state dairy herd of a BSE-positive cow imported from Canada, USDA issued new regulations containing additional safeguards to further minimize risk for introduction of the BSE agent into the U.S. food supply. See USDA's website www.usda.gov for further information.

Similarly, FDA has prohibited the use of the cattle materials that carry the highest risk of BSE in human food, including dietary supplements, and in cosmetics. FDA's rule (and September 2005 amendments) prohibit use of the following cattle material in human food and cosmetics:

cattle material from non-ambulatory, disabled cattle,
cattle material from organs from cattle 30 months of age or older in which infectious prions are most likely to occur, and the tonsils and the distal ileum of the small intestine of cattle of all ages,
cattle material from mechanically separated (MS) (beef), and
cattle material from cattle that are not inspected and passed for human consumption
FDA's rule also requires that food and cosmetics manufacturers and processors make available to FDA any existing records relevant to their compliance with these prohibitions. FDA has also published a proposal requiring manufacturers and processors of food and cosmetics made with cattle material to establish and maintain records demonstrating that their products do not contain prohibited cattle material.

In September 2005, FDA amended the interim final rule to allow use of the small intestine in human food and cosmetics, provided the distal ileum has been removed. FDA also clarified that milk and milk products, hide and hide-derived products and tallow derivatives are not considered prohibited cattle materials. Finally, in response to comments the agency has reconsidered the method cited in the interim final rule for determining insoluble impurities in tallow and is citing a method that is less costly and requires less specialized equipment.

Are the protective measures in place sufficient to ensure the safety of the human food supply in light of the June 2005 BSE positive cow?
Yes, the protective measures put into place in July 2004 by FDA ensure that cattle materials that carry the highest risk of transmitting the agent that causes BSE are excluded from human food, including dietary supplements, and cosmetics. These measures, along with similar measures established by USDA, provide a uniform national BSE policy and ensure the safety of human food.

Is the food in the U.S. likely to be a BSE risk to consumers?
FDA and other federal agencies have had preventive measures in place to reduce the U.S. consumer's risk of exposure to any BSE-contaminated meat and food products. Since 1989, USDA has prohibited the importation of live animals and animal products from BSE-positive countries. Subsequently, USDA expanded the ban to include both countries with BSE and countries at risk for BSE. Since 1997, FDA has prohibited the use of most mammalian protein in the manufacture of ruminant feed. In 2004, FDA issued a rule prohibiting the use of certain cattle materials in human food and cosmetics, and USDA issued a rule prohibiting certain cattle materials from use as human food.

Is cow's milk a source of BSE?
Scientific research indicates that BSE is not transmitted in cow's milk, even if the milk comes from a cow with BSE. Milk and milk products, even in countries with a high incidence of BSE are, therefore, considered safe.

Can milk be infected with BSE from a BSE-positive cow?
No detectable infectivity in cow's milk has been reported from any BSE-infected cows. Infectious prions have not been detected by bioassay of milk from cattle with BSE.

Does the use of bovine-derived ingredients in dietary supplements mean that they are not safe?
No. The requirements that FDA has in place should give consumers confidence that their food, including dietary supplements, is safe. Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. The rule applies to both imported and domestic dietary supplements and their ingredients. Furthermore, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive. It is not a common occurrence for animals younger than 30 months to develop BSE.

Since the BSE-positive cows were discovered in the U.S., does that mean that dietary supplements made with domestic ingredients might be unsafe?
No. The requirements that FDA has in place should give consumers confidence that their food, including dietary supplements, is safe. Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. Furthermore, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive.

Even though BSE-positive cows have been identified in the U.S., one of which was imported, the risk to human health from dietary supplements and other foods containing cattle-derived ingredients is extremely low.

What steps is FDA currently taking to ensure the safety of dietary supplements that contain bovine ingredients?
Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. The rule applies to both domestic and imported dietary supplements and their ingredients. In addition, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive. Further, the restrictions by USDA on the use of certain cattle and cattle tissues in human food also reduce the risks that potentially infective tissue would be used in dietary supplements. FDA also has proposed a requirement that manufacturers and processors that use cattle material in their products would be required to keep records demonstrating that these materials do not contain prohibited cattle material and that these records be made available to FDA for inspection.

Given the BSE case in Washington State and the case in Texas, should consumers be concerned about cosmetics made using tallow from the rendering process?
No. The World Health Organization considers tallow to be a low risk for transmission of BSE. Specifically, the rendering process separates fats from proteins. Because the disease is transmitted by prions, which are a type of protein, they would be separated by the rendering process from the tallow or fat, which is the portion that goes into cosmetics. Additionally, the tallow is processed with excessive heat and pressure which may further minimize any risk of infectivity prior to use in cosmetics.

What about the use of gelatin, another bovine-related material, in cosmetics and dietary supplements and other foods?
FDA's rule prohibiting the use of the cattle materials that have the highest risk of harboring BSE infectivity in human food applies to gelatin. Therefore, gelatin used in human food may not be made from these cattle materials.

When and how did BSE in cattle occur?
BSE in cattle was first reported in 1986 in the United Kingdom (UK). The exact origins of BSE remain uncertain, but it is thought that cattle initially may have become infected when fed feed contaminated with scrapie-infected sheep meat-and-bone meal (MBM). Scrapie is a prion disease in sheep similar to BSE in cattle. The scientific evidence suggests that the U.K. BSE outbreak in cattle then was expanded by feeding BSE-contaminated cattle protein (MBM) to calves. The definitive nature of the BSE agent is not completely known. The agent is thought to be a modified form of a protein, called a prion, which becomes infectious and accumulates in neural tissues causing a fatal, degenerative, neurological disease. These abnormal prions are resistant to common food disinfection treatments, such as heat, to reduce or eliminate their infectivity or presence. Research is ongoing to better understand TSE diseases and the nature of prion transmission.

Is BSE in cattle the same disease as CWD in deer and elk in the U.S.?
BSE is a Transmissible Spongiform Encephalopathy (TSE), a family of similar diseases that may infect certain species of animals and people such as scrapie in sheep and goats, BSE in cattle, chronic wasting disease (CWD) in deer and elk, and variant Creutzfeldt-Jakob disease (vCJD) in people.

To date, there is no scientific evidence that BSE in cattle is related to CWD in deer and elk. FDA is working closely with other government agencies and the public health community to address CWD in wild and domesticated deer and elk herds. Wildlife and public health officials advise people not to harvest, handle, or consume any wild deer or elk that appear to be sick, regardless of the cause, especially in those states where CWD has been detected.

What countries have reported cases of BSE or are considered to have a substantial risk associated with BSE?
These countries are: Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Federal Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Liechtenstein, Luxembourg, former Yugoslavia Republic of Macedonia, The Netherlands, Norway, Oman, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Japan, and United Kingdom (Great Britain including Northern Ireland and the Falkland Islands).


--------------------------------------------------------------------------------

This document was issued in January 2004 and updated in July 2004 and June 2005.
For more recent information on Bovine Spongiform Encephalopathy (BSE)
see http://www.fda.gov/oc/opacom/hottopics/bse.html


http://www.cfsan.fda.gov/~comm/bsefaq.html



FDA News
FOR IMMEDIATE RELEASE
P05-58
September 6, 2005
Media Inquiries:
Michael Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Amends Interim Final Rule "Use of Materials Derived from Cattle in Human Food and Cosmetics"
The U.S. Food and Drug Administration today published several amendments to the July 2004 interim final rule, "Use of Materials Derived from Cattle in Human Food and Cosmetics," that will allow the use of certain cattle-derived material in human foods and cosmetics.

The rule prohibits the use of cattle-derived materials that can carry the infectious agent for bovine spongiform encephalopathy (BSE), or mad cow disease, in human foods, dietary supplements, and in cosmetics. Based on the scientific information provided during the interim final rule's comment period, which demonstrates that a part of the cow's digestive tract called the distal ileum can be consistently and effectively removed from the other sections of the small intestine, it is no longer necessary to designate the entire small intestine as a prohibited cattle material.

As a result, FDA is amending the rule to allow use of the small intestine in human food and cosmetics, provided that the distal ileum has been removed. The U.S. Department of Agriculture is publishing today a similar amendment to its interim final rule on BSE.

The amendments also clarify that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited for use in human food and cosmetics.

Finally, FDA has reconsidered the recommended method for determining insoluble impurities in a type of solid fat known as tallow, in response to information submitted to the agency, to cite a method that is less costly to use and requires less specialized equipment.

FDA issued the interim final rule to minimize human exposure to materials that studies have demonstrated are highly likely to contain the BSE agent in cattle with the disease. The amended interim final rule provides the same level of protection against the agent that causes BSE as the original provisions.

The amendments to the interim final rule are effective on October 7, 2005 and comments are being are accepted on the amendments through November 7, 2005.

####

http://www.fda.gov/bbs/topics/news/2005/NEW01229.html

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


FDA sets BSE-related rules but delays action on feed
Robert Roos News Editor


Jul 9, 2004 (CIDRAP News) – The Food and Drug Administration (FDA) said today it is banning cattle parts that could contain the bovine spongiform encephalopathy (BSE) agent from food supplements and cosmetics, but it is not yet ready to ban those parts from all feed for animals, including pets.

The FDA had announced plans in January to ban high-risk cattle tissues, or "specified risk materials" (SRMs), from food, food supplements, and cosmetics. But the agency never officially imposed the ban. Officials said today it would take effect Jul 14, when it will be published in the Federal Register.

The US Department of Agriculture (USDA), which regulates meat, poultry, and eggs, banned SRMs from those foods in January, following the discovery of a BSE case in Washington state in December. The FDA regulates all other foods, as well as supplements and cosmetics.

The FDA said today it has reached a "preliminary" decision to ban SRMs from all animal feed, but it wants to gather public comments before going ahead. In a telephone briefing, officials said the agency would take comments for 60 to 120 days.

"FDA has reached a preliminary conclusion that it should propose to remove SRM's from all animal feed and is currently working on a proposal to accomplish this goal," the agency said in a news release. The agency is issuing an "advance notice of proposed rulemaking" on the topic.

Cattle contract BSE, or mad cow disease, by eating feed containing protein from other infected cattle. To prevent the spread of BSE, the FDA in 1997 banned the practice of putting cattle-derived protein in feed for cattle and other ruminant animals. However, cattle tissues are still used in feed for pigs, chickens, and pets.

The aim of the new proposed rule is to prevent cross-contamination, whereby SRMs in cattle parts used in feed for pigs, chickens, or pets could end up in cattle feed if both kinds of feed are made with the same equipment or in the same plant. Cross-contamination also can occur if cattle are given feed intended for other animals.

The FDA's notice of proposed rulemaking also calls for public comments on other possible actions to block pathways by which material from BSE-infected cattle could get into cattle feed. These actions include:

Requiring that equipment for handling and storing feed be dedicated to just one kind of feed (for either ruminants or nonruminants)
Banning the use of all mammalian and poultry protein in ruminant feed
Banning the feeding of mammalian blood to calves
Prohibiting the use of poultry litter (which includes bedding, spilled feed, and waste) and restaurant leftovers in cattle feed
Banning the use of nonambulatory ("downer") cattle and cattle that die on farms in any animal feed
In its announcement in January, the FDA had described plans to ban the feeding of mammalian blood to calves, halt the use of poultry litter and restaurant leftovers in cattle feed, and require "dedicated equipment" in feed handling and storage. But the agency never followed through on those restrictions at the time.

Today the FDA said that banning SRMs from all animal feed could render unnecessary some of the other possible steps for reducing feed-related risks. Such a ban was a key recommendation from an international team of experts that reviewed the USDA's actions on BSE early this year, FDA officials said.

The international review team (IRT) released its report about a week after the FDA's January announcement. The team said the single most important measure for reducing feed-related BSE risks was to eliminate SRMs from all animal feed, Steve Sundlof of the FDA's Center for Veterinary Medicine said today.

"The IRT approach is to prevent potentially infective tissues from ever entering animal feed channels," the FDA's notice of proposed rulemaking says. "Although FDA believes the measures previously announced would serve to reduce the already small risk of BSE spread through animal feed, the broader measures recommended by the IRT, if implemented, could make some of the previously announced measures unnecessary."

However, "either approach would require a significant change in current feed manufacturing practices," the notice states. "Therefore, the FDA believes that additional information is needed to determine the best course of action."

Sundlof said there is concern that banning poultry litter from cattle feed would cause disposal problems. The litter would have to be disposed of on land, which might mean it would end up on cattle pastures, he said.

In response to questions, Sundlof said he couldn't specify the amount of SRMs that are currently used in animal feed, but he said that dealing with them would be "a complicated issue" if they were banned. "It would most likely require that the rendering industry at least partially restructure to include a sector that is for disposal only," he said.

SRMs, as defined by USDA and FDA, include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column, and dorsal root ganglia of cattle aged 30 months or older, plus the tonsils and small intestine of all cattle. In BSE-infected cattle, these are the tissues most likely to contain infectious prion protein.

In addition to SRMs, certain other cattle materials will be banned from foods, supplements, and cosmetics, the FDA said. These include material from downer cattle and cattle not inspected and approved for human consumption, plus mechanically separated beef.

FDA officials today said the percentage of food supplements and cosmetics that contain SRMs is very small, but they couldn't give a specific number.

See also:

Jul 9 news release from FDA and USDA
http://www.fda.gov/bbs/topics/news/2004/NEW01084.html

FDA fact sheet on final rule concerning foods and cosmetics
http://www.cfsan.fda.gov/~comm/bsefact2.html

FDA-USDA advance notice of proposed rulemaking (53 pages)
http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0264-nap0001.pdf

Jan 26, 2004, news release on BSE-related rules planned by FDA at that time
http://www.hhs.gov/news/press/2004pres/20040126.html

http://www.cidrap.umn.edu/cidrap/content/other/bse/news/july0909bse.html

FDA sets rules to keep BSE out of food, supplements
Robert Roos News Editor


Jan 27, 2004 (CIDRAP News) – In response to the discovery of bovine spongiform encephalopathy (BSE) in a US cow last month, the Food and Drug Administration (FDA) yesterday announced a lengthy set of new rules to shield FDA-regulated foods and food supplements from BSE-contaminated material.

The rules include a ban on feeding mammalian blood to calves and a ban on the use of downer cattle and high-risk cattle tissues such as the brain and spinal cord in FDA-regulated products. In addition, the FDA is prohibiting the feeding of poultry litter and restaurant scraps to cattle and the use of "mechanically separated" beef in food.

The US Department of Agriculture (USDA), which regulates meat, poultry, and egg products, on Dec 30 banned the processing of downer cattle—those too sick or injured to stand at the time of slaughter—for food. The FDA regulates all other foods, including processed foods that contain meat, such as soups and pizza, along with food supplements and cosmetics.

In announcing the rules yesterday, Secretary of Health and Human Services (HHS) Tommy Thompson said they will add to a set of five existing "firewalls" protecting the public from BSE contamination. "Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible," he said in a news release.

Cattle contract BSE by eating feed containing material from other infected cattle. Eating meat products from infected cattle is believed to be the cause of variant Creutzfeldt-Jakob disease (vCJD), a human neurologic disease similar to BSE.

The new FDA rules will take effect when they are published in the Federal Register, but public comments will be invited after publication, the agency said.

The FDA rules ban the following items from the foods, supplements, and cosmetic products it regulates:

Any material from downer cattle or dead cattle (cattle that die before reaching a slaughter plant)
Specified risk materials (SRMs), or high-risk tissues, which include the brain, skull, eyes, and spinal cord of cattle 30 months or older and the tonsils and part of the small intestine from all cattle
Mechanically separated beef, which may contain high-risk tissues, but not beef from advanced meat recovery (AMR) systems. Mechanically separated beef may contain crushed or ground bones, while AMR systems separate meat without breaking bones. USDA rules bar SRMs from AMR-produced products.
The ban on feeding mammalian blood to calves closes a loophole in the FDA's 1997 ban on feeding parts from cattle and other ruminant animals to ruminants, HHS said. Under the 1997 rule, blood and blood products could still be fed to ruminants, and cattle blood is currently fed to calves as a milk replacement in some cases.

"Recent scientific evidence suggests that blood can carry some infectivity for BSE," the announcement said. That might have been a reference to a recent report from Britain of a person who contracted vCJD several years after receiving blood from someone else who was found to have the same disease.

The FDA is banning the use of poultry litter in cattle feed because it may contain spilled poultry feed that includes cattle parts, officials said. Poultry litter consists of bedding, spilled feed, feathers, and waste collected from poultry sheds. It is used in cattle feed in some areas where cattle and large poultry operations are close together, the FDA said. Cattle parts can legally be used in feed for poultry and hogs.

The new rule banning restaurant "plate waste" in cattle feed is intended to protect the FDA's ability to enforce the ban on using cattle parts in cattle feed, the FDA said. Plate waste includes meat scraps, which are collected from some restaurants for use in feed. Its presence "confounds" the FDA's ability to detect prohibited proteins in cattle feed, officials said.

The FDA also said it will require feed plants to use separate production equipment to make feed for nonruminant animals (such as poultry and hogs) if the feed contains proteins banned from cattle feed. Currently, some equipment is used to process both banned and permitted materials, which can lead to cross-contamination of cattle feed with banned materials.

The FDA also promised to step up its inspections of feed mills and rendering plants this year. The agency said it will inspect 2,800 plants and will fund another 3,100 inspections by state agencies. Officials said their goal is to inspect all known renderers and feed mills that process products containing materials banned from cattle feed.

See also:

FDA news release
http://www.hhs.gov/news/press/2004pres/20040126.html

http://www.cidrap.umn.edu/cidrap/content/other/bse/news/jan2704fda.html

Journal of Virology, February 2005, p. 1888-1897, Vol. 79, No. 3
0022-538X/05/$08.00+0 DOI: 10.1128/JVI.79.3.1888-1897.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.
Neuroinvasion by Scrapie following Inoculation via the Skin Is Independent of Migratory Langerhans Cells
Joanne Mohan, Moira E. Bruce, and Neil A. Mabbott*

Neuropathogenesis Unit, Institute for Animal Health, Edinburgh, Scotland, United Kingdom

Received 18 June 2004/ Accepted 7 September 2004

Many natural transmissible spongiform encephalopathy (TSE) infections are likely to be acquired peripherally, and studies in mice show that skin scarification is an effective means of scrapie transmission. After peripheral exposure, TSE agents usually accumulate in lymphoid tissues before spreading to the brain. The mechanisms of TSE transport to lymphoid tissues are not known. Langerhans cells (LCs) reside in the epidermis and migrate to the draining lymph node after encountering antigen. To investigate the potential role of LCs in scrapie transportation from the skin, we utilized mouse models in which their migration was blocked either due to CD40 ligand deficiency (CD40L–/– mice) or after caspase-1 inhibition. We show that the early accumulation of scrapie infectivity in the draining lymph node and subsequent neuroinvasion was not impaired in mice with blocked LC migration. Thus, LCs are not involved in TSE transport from the skin. After intracerebral inoculation with scrapie, wild-type mice and CD40L–/– mice develop clinical disease with similar incubation periods. However, after inoculation via skin scarification CD40L–/– mice develop disease significantly earlier than do wild-type mice. The shorter incubation period in CD40L–/– mice is unexpected and suggests that a CD40L-dependent mechanism is involved in impeding scrapie pathogenesis. In vitro studies demonstrated that LCs have the potential to acquire and degrade protease-resistant prion protein, which is thought to be a component of the infectious agent. Taken together, these data suggest that LCs are not involved in scrapie transport to draining lymphoid tissues but might have the potential to degrade scrapie in the skin.

* Corresponding author. Mailing address: Institute for Animal Health, Neuropathogenesis Unit, Ogston Bldg., West Mains Rd., Edinburgh EH9 3JF, United Kingdom. Phone: 44(0)131-667-5204. Fax: 44(0)131-668-3872. E-mail: neil.mabbott@bbsrc.ac.uk.

Journal of Virology, February 2005, p. 1888-1897, Vol. 79, No. 3
0022-538X/05/$08.00+0 DOI: 10.1128/JVI.79.3.1888-1897.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

http://jvi.asm.org/cgi/content/abstract/79/3/1888?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=prion&searchid=1105649944632_5001&stored_search=&FIRSTINDEX=0&volume=79&issue=3&journalcode=jvi

2003 - 2004 Product Catalog

Standard Process Inc.


NATURAL COCOA STANDARDBAR (mad cow candy bar)
(i will just list animal organs)
bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

NATURAL PEANUT BUTTER STANDARDBAR

bovine adrenal, bovine liver, bovine spleen, ovine spleen, bovine kidney...

USF (MAD COW) OINTMENT (RUB A DUB DUB, KURU ETC) ;

bovine orhic glandular extract

UTROPHIN PMG

bovine uterus PMG

VASCULIN

bovine heart PMG extract, veal bone PMG extract, bovine liever, porcine
duodenum,
bovine adrenal Cytosol extract, bovine spleen, ovine spleen (some yummy
stuff)

IPLEX (neighbors mom died from CJD while taking these pills for years)

bovine eye PMG extract, veal bone PMG, bovine liver, porcine stomach,
bovine adrenal,
bovine kidney, bovine adrenal Cytosol extract, BOVINE BRAIN, bovine
bone, veal bone
meal

MYO-PLUS

bovine heart PMG, bovine liver, porcine stomach, bovine orchic extract,
bovine
spleen, ovine spleen, bovine adrenal Cytosol extract, BOVINE BRAIN

NEUROPLEX

bovine orchic Cytosol extract, bovine spleen, BOVINE BRAIN PMG EXTRACT,
BOVINE ANTERIOR PITUITARY, bovine liver, BOVINE PITUITARY PMG EXTRACT,
AND MORE BOVINE BRAIN... HOLY MAD COW IN A PILL !!!

NEUROTROPHIN PMG

BOVINE BRAIN PMG

NIACINAMIDE B6 VM

bovine liver, porcine stomach, bovine spleen ovine spleen,
BOVINE BRAIN

OCULOTROPHIN PMG
BOVINE EYE PMG

ORCHEX

bovine liver, bovine orchic Cytosol extract, porcine stomch,
bovine spleen, ovine spleen, BOVINE BRAIN

OSTARPLEX

veal bone PMG extract, veal bone PMG extract, bovine liver,
porcine stomach, bovine adrenal, bovine spleen, ovine spleen,
BOVINE BRAIN

PARAPLEX

bovine pancreas PMG extract, porcine duodenum, bovine adrenal PMG,
BOVINE PITUITARY PMG EXTRACT, bovine thyroid PMG extract

PITUITROPHIN PMG

RUMAPLEX

BOVINE BRAIN, veal bone PMG extract, bovine adrenal, bovine prostate
Cytosol extract, veal bone meal, bovine liver PMG extract, bovine spleen,
ovine spleen, bovine liver

SENAPLEX

bovine liver PMG extract, bovine adrenal, BOVNE BRAIN, veal bone meal,
bovine
kidney, bovine orchic extract, bovine spleen, ovine spleen ..........

THESE are just a few of MANY of just this ONE COMPANY...TSS

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm

as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE ;


Published online

January 27, 2005

http://image.thelancet.com/

F Mouthon DipBiol, F Auvré,

Risk of oral infection with bovine spongiform

encephalopathy agent in primates

Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia,

Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys

The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)—which can lead to variant

Creutzfeldt-Jakob disease (vCJD)—is compounded by incomplete knowledge about the ef.ciency of oral infection

and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral

transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a

BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the

other remained free of disease at 76 months. On the basis of these .ndings and data from other studies, we made a

preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public

health measures can prevent transmission of BSE to man.

BSE bovine brain inoculum

100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg

Primate (oral route)* 1/2 (50%)

Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)

RIII mice (icip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)

PrPres biochemical detection   

The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was

inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the .rst positive animal (%). The accuracy of

bioassays is generally judged to be about plus or minus 1 log. icip=intracerebral and intraperitoneal.

Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula

Published online January 27, 2005 http://image.thelancet.com/extras/05let1056web.pdf

TSS




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