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From: TSS ()
IMPORTANT NOTICE - Revised Policy Regarding Gelatin in Natural Health Products Subject: EFSA RISK ASSESSMENT FOR ONLY BSE by Bovine Vertebral Column including Dorsal Root Ganglia to humans www.efsa.eu.int 1 Opinion of the Scientific Panel on Biological Hazards of the European Food Safety Authority on the “Quantitative assessment of the Human BSE risk posed by Bovine Vertebral Column including Dorsal Root Ganglia with respect to residual BSE risk”1 (Question N° EFSA-Q-2003-099) Adopted on 18 May 2006 SUMMARY 1.1. Residual BSE risk due to Bovine Vertebral Column The European Food Safety Authority (EFSA) quantitative risk assessment (QRA) guidance document gives residual Bovine Spongiform Encephalopathy (BSE) risk assessments for byproducts – tallow, gelatine and calcium phosphates – used in human food obtained from cattle fit for human consumption (EFSA QRA report, 2004). The effect of including vertebral column in the batch of raw materials used for the production of the by-products was calculated as part of separate risk assessments for these materials. The Commission Mandate to EFSA asked the Panel to review the “Opinion and report, assessment of the human BSE risk posed by bovine vertebral column including dorsal root ganglia (adopted on 16 May 2002)” in the light of their QRA on residual BSE risk and, if appropriate, revise the 2002 Opinion accordingly. This revision covers the by-products, tallow and gelatine, but does not consider the human risk from consumption of meat on the bone or the inclusion of bovinederived phosphates as food additives, or the effect of changing the age limit for regarding vertebral column as specified risk material. The EFSA Opinions on tallow and gelatine give descriptions of manufacturing processes, the various assumptions relating to their QRA and the background considerations relating to the interpretation of the output values. In this document we simply reproduce the relevant conclusions and recommendations of those opinions relating to the inclusion of vertebral column and the production of these by-products. 1 For citation purposes: Opinion of the Scientific panel on Biological Hazards on “Quantitative assessment of the Human BSE risk posed by Bovine Vertebral Column including Dorsal Root Ganglia with respect to residual BSE risk”, The EFSA Journal (2006), 359, 1-3 Summary of Opinion www.efsa.eu.int 2 Some illustrative data is shown below for the range of median (P50) exposure estimates (units, Cattle oral infectious dose 50%, CoID50/person/week)2. For detailed results see table 1 further in this document. GBR II† GBR III GBR IV Tallow De-Greasing bones * * 10-12 to 10-11 Mixture of tissues * * 10-12 to 10-10 Gelatine Acid & Alkaline * * 10-9 to 10-8 Heat & Pressure * * 10-11 to 10- 10 The logic of interpreting the CoID50 units of exposure in terms of human risk is essentially that assuming a species barrier of 1, and all the other assumptions, an exposure value > 10-8 per time period may result in one or more cases of vCJD per time period. The only scenario in which the P50 values approach the 10-8 level is in the production of gelatine from bovine bones by the acid and alkaline method. Referring back to the gelatine opinion, this is a worst case consumption scenario where all the daily human dose of gelatine is assumed to be bovine bone derived (when it is more likely to be 1-5%). Similarly, for more realistic sourcing scenarios such as a GBR III country with reliable surveillance, even the P97.5 values only approach 10-8 for gelatine produced from bovine bones by the acid and alkaline method (and a worst case consumption input). 1.2. Conclusion of this revision • Inclusion of vertebral column in the raw materials used to produce tallow and gelatine from bones or a mixture of tissues increases the level of human exposure by ~ 3-10 fold. However, the levels of residual BSE risk for these products calculated in the QRA are low and the increased risk factor due to inclusion of vertebral column is unlikely to translate into further cases of vCJD in the population. Therefore, in the case of tallow and gelatine, there appears to be no rationale for imposing an age-limit above which to exclude vertebral column from the batches of raw materials used to produce these by-products. • The human risk from consumption of meat on the bone or the inclusion of bovine-derived phosphates as food additives could be estimated using the QRA model if the appropriate input data for human consumption were available. 1.3. Further recommendations of the BIOHAZ Panel during the adoption of this report at their Plenary Meeting, 17-18th May, 2006 • This is the final Report to be revised in the light of the EFSA BSE QRA guidance document (EFSA QRA report, 2004), and joins a series covering a range of residual BSE risk assessments on the cattle by-products : tallow, gelatin, and calcium phosphates. Each revision considers the separate effects of the QRA on the risk of exposure to human and/or cattle population for each by-product. The Panel recognised the need to evaluate the cumulative effect of each incremental change in exposure to the populations calculated in 2 * in this Table is defined as an exposure level of < 10-13 CoID50 units/person/per week. † GBR: Geographical BSE Risk Summary of Opinion www.efsa.eu.int 3 these revisions, and recommended that this “total” exposure assessment be carried out in the near future. • “Gaps” in these residual risk assessments were inevitable due to the restricted scope of the original EFSA BSE QRA guidance document, and the Panel recommended that these gaps should be addressed by future Panel members using their “self-tasking mandate” option. For example, in the context of this vertebral column document, the QRA model could be used to estimate the human risk from consumption of meat on the bone or the inclusion of bovine-derived phosphates as food additives. • The EFSA BSE QRA guidance document was written almost four years ago, and although some parts have been revised since then to accommodate new research findings, the methodology and nomenclature for defining the geographical BSE risk (GBR) input to the model is no longer appropriate. New methodology, under the auspices of the OIE, is under construction within the EU and EFSA and the Panel recommended that once these classifications had been finalised they should harmonised with those used in the EFSA BSE QRA guidance document. The Panel anticipated that this harmonisation may have a knock-on impact on the QRA calculations, conclusions and recommendations and that, again, future Panel members should review this, and other, inputs of the QRA and address this impact using their “self-tasking mandate” option. >>>New methodology, under the auspices of the OIE, is under construction within the EU and EFSA and the Panel recommended that once these classifications had been finalised they should harmonised with those used in the EFSA BSE QRA guidance document. The Panel anticipated that this harmonisation may have a knock-on impact on the QRA calculations, conclusions and recommendations and that, again, future Panel members should review this, and other, inputs of the QRA and address this impact using their “self-tasking mandate” option.<<< WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ??? see full text ; http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic The NHPD will be sending notices to licensees of approved natural health products as well as applicants of products currently under licensing review asking them either to replace their gelatin with materials that are not susceptible to containing the causative agent of a TSE or to provide documentation demonstrating that appropriate quality control measures have been undertaken. Further details are provided below. Affected licensees and applicants are advised to carefully read and comply with the instructions and requirements outlined below. Licensees that cannot adequately demonstrate that their gelatin meets these requirements will be subject to compliance action. Those individuals receiving notices from the NHPD are asked to comply with the request within the indicated timeframe. Recommended Materials for Use in Gelatine for Natural Health Products The NHPD recommends that manufacturers use any of the following materials in their product as these materials are not contaminated with the causative agent of a TSE: plant materials (e.g. vegicaps), or While the NHPD strongly encourages all manufacturers of natural health products to use the gelatin source materials or substitutes listed above, where this is not possible, the Directorate will allow manufacturers to continue to use gelatin made from the bones of cattle, sheep, goat, deer, and elk , provided that A) the bones do not include skull or vertebral column and B) the manufacturer includes one of the following with their Product Licence Application: Authorization to access an existing Drug Master File (DMF) which has been approved by Health Canada, in which the risk associated with TSE/BSE has been properly addressed during the DMF assessment, or Bones are finely crushed, degreased with hot water and demineralised with dilute hydrochloric acid (> 4%, pH<1.5) for a minimum of two days to obtain collagen. This is followed by an alkaline treatment with saturated lime solution (pH>12.5) for at least 20 days. The gelatin is extracted, washed, filtered and concentrated. Then a heat treatment (sterilization at 138-140 oC, for 4 seconds) is applied, or NOTE FOR COMPENDIAL PRODUCT LICENCE APPLICATIONS : Option A is acceptable. Applicants choosing options B or C will see their compendial applications transferred to the non-compendial stream for further review. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/bulletins/gelatin_gelatine_e.html FOR IMMEDIATE RELEASE Contact: Matthew Freeman January 14, 2004 301-762-8980 CPR Raps USDA’s Veneman for Mad Cow Regs ‘New Regulations Riddled with Loopholes, Fail to Protect Consumers’ Washington, DC ---- Center for Progressive Regulation President Tom McGarity today called on Secretary of Agriculture Ann M. Veneman to go back to the drawing board with recent regulations issued by the department to protect the American consumer from Mad Cow and other beef-related illnesses. On Thursday, January 8, the Department released a series of new regulations, following up on Veneman’s December 30 declaration that “For more than a decade, the United States has had in place an aggressive surveillance, detection and response program for BSE. While we are confident that the United States has safeguards and firewalls needed to protect public health, these additional actions will further strengthen our protection systems.” The Secretary’s words and tone were consistent with what McGarity calls “the Administration’s ‘cheerleading for agri-business.’” “Since the beginning,” McGarity said in releasing his letter, “the Administration’s approach to this problem has been to combat Mad Cow disease with public relations initiatives, assuring us that the Secretary was serving beef for Christmas, but taking no significant steps to improve the current testing regime. These new regulations were a missed opportunity for the Administration to get serious about tightening up food safety requirements. The regulations are so full of loopholes that they will do little to protect the American consumer.” McGarity is a professor of food safety law at the University of Texas Law School and President of the Center for Progressive Regulation. He voiced his specific objections about the regulations in a letter to Veneman, delivered Tuesday, January 13. The letter urges the Department to reconsider its trust-the-industry approach to regulating this vital matter of food safety. CPR called for USDA to “promulgate a rule requiring that all cattle be tested for BSE prior to slaughter for human consumption and expand its . . . product holding guideline to include all BSE-tested cattle.” The new package of regulations contains two that are of little relevance, according to McGarity, writing: “Both the [new] ban on air injection stunning and the ban on mechanically separated meat imposed no burden whatsoever on the cattle industry and will not enhance the safety of meat, because neither technology is currently used in the U.S. It seems disingenuous at best for USDA to claim credit for taking action that will have no impact one way or the other.” Two of the remaining regulations announced by USDA are intended to ensure that certain parts of slaughtered cows (specific risk material or SRM) are not included in human food (eyes, brain matter, etc.). But these two regulations are marred by huge loopholes. Says McGarity in the letter: The SRM regulation does not specify “ the procedures and techniques that establishments must use to ensure that Special Risk Material . . . does not enter the food supply. Establishments are only required to come up with ‘written procedures’ for the ‘removal, segregation, and disposition of SRMs.’ The same is true for the rule governing Advanced Meat Recovery Systems (AMRS). USDA promises to ‘ensure the adequacy and effectiveness’ of each establishment’ s procedures, but it does not say how it will do that. And the rules provide no legally enforceable way for USDA to fulfill its promise, in any event. In short, there are no requirements for how establishments must go about removing SRM from food. There is only a general prohibition on the use of SRM for human food and the aspiration that companies will at some point in the future come up with adequate individual plans to remove SRM from food. USDA does not specify any criteria for the plans that establishments must draft. The regulations do not even specify how companies should go about determining whether meat at the end of the production process contains SRMs. The establishments are free to do whatever they want. There is not even a deadline for preparing the plan.” A second loophole permits the use of SRM from cattle less than 30 months old. Writes McGarity: “ The loophole for cattle less than 30 months old is not well supported. BSE [Mad Cow Disease] has been found in animals that were younger than 30 months old….While it may be true that younger cattle pose fewer risks, they are by no means risk-free. USDA does not explain why U.S. consumers should be intentionally subjected to such a high-consequence risk, even if the probability is low. Finally, the rules create a final loophole for bone marrow, even though USDA has acknowledged that bone marrow was determined to be infective in one experiment. Nevertheless, writes McGarity, “Bone marrow is not included in the definition of ‘specified risk material.’ The loophole for bone marrow is not well justified. USDA acknowledges that bone marrow was determined to be infective in one experiment, but it has elected not to include it as a Specified Risk Material. The only rationale provided is that the ‘findings were not conclusive.’ SRM Rule at 18. USDA should not await a ‘conclusive’ study before taking action to prevent exposing the U.S. population to a risk of BSE. The statute mandates a precautionary approach that does not require ‘conclusive’ demonstration that a meat food product will cause adverse health effects. It requires only that the meat contain a deleterious substance that ‘may render it injurious to health.’ 21 U.S.C. § 601(m)(1).” In a recent op-ed published in the Dallas Morning News, available at http://www.dallasnews.com/opinion/viewpoints/stories/010604dnedimcgarity.112f32 67a.html, McGarity called for a truly independent agency to oversee the food supply. He wrote: “Unfortunately, consumers can't rest comfortably because both the Agriculture Department and FDA report directly to the White House and therefore are subject to political pressures from one of the Bush administration's favorite constituencies – the meat industry. Congress should lodge the rule-making and enforcement functions of the meat safety laws in an independent agency whose primary responsibility isn't ensuring the economic well-being of agribusiness. The new agency shouldn't be subject to the political control of the White House, and it shouldn't be overseen by the House and Senate agriculture committees. Stringent food safety laws are critical to consumer confidence in the food supply, and they must be implemented and enforced by a strong federal regulator, not a cheerleader for the regulated industry.” The complete text of McGarity’ s letter is available on CPR’ s website at www.progressiveregulation.org. Founded in 2002, the Center for Progressive Regulation is a nonprofit research and educational organization of university-affiliated academics with expertise in the legal, economic, and scientific issues related to regulation of health, safety, and the environment. CPR supports regulatory action to protect health, safety, and the environment. Through research and commentary, CPR seeks to inform policy debates, critique anti-regulatory research, enhance public understanding of the issues, and open the regulatory process to public scrutiny. For a copy of McGarity’s letter, or to arrange interviews, contact Matthew Freeman at 301-762-8980, or at mfreeman@progressiveregulation.org. Visit CPR on the web at www.progressiveregulation.org. -- 30 -- http://www.progressiveregulation.org/articles/Mad_Cow_Letter_Veneman_NR.pdf WHITE PAPER http://www.progressiveregulation.org/articles/mad_cow_exec.pdf HARKIN LAYS OUT CONCERNS OVER USDA PLAN TO EXPAND CANADIAN CATTLE, BEEF IMPORTS TUESDAY, FEBRUARY 1, 2005 February 1, 2005 Additionally, the U.S. Food and Drug Administration (FDA) has not yet taken final action on its proposed expansion of the U.S. ruminant feed ban to include plate waste and poultry litter. Taken as a whole, these facts present a pathway through which there is some risk (quite small yet still significant given the consequences of BSE) that BSE could enter the U.S. feed supply. Given the uncertainty about whether Canada truly fits the OIE minimum risk profile, USDA should strengthen, not abandon existing measures, such as requiring the removal of SRMs in animals 20-30 months of age that are slaughtered to provide beef for export to the U.S. At the very least USDA should continue a ban on beef products from cattle over 30 months old until these concerns are addressed. Sincerely, Tom Harkin Kent Conrad Tim Johnson Ken Salazar http://harkin.senate.gov/news.cfm?id=231310 HARKIN: INSPECTOR GENERAL REPORT SHOWS PROGRESS, BUT SIGNIFICANT SHORTFALLS REMAIN IN USDA’S ANTI-BSE EFFORTS http://harkin.senate.gov/news.cfm?id=251102 Release No. 0143.06 "Our enhanced BSE surveillance program has been an enormous undertaking, but well worth the effort," said Johanns. "We can now say, based on science, that the prevalence of BSE in the United States is extraordinarily low. The testing and analysis reinforce our confidence in the health of the U.S. cattle herd, while our interlocking safeguards, including the removal of specified risk materials and the feed ban, protect animal and human health." The estimate of BSE prevalence in the United States is based on data gathered from not only the enhanced surveillance effort that has been underway since June 2004, but also from surveillance conducted in the United States for the 5 years prior. USDA experts used two different methods, the BSurvE Prevalence B method and the Bayesian birth-cohort method, to analyze the prevalence of BSE based on all of the surveillance data. The findings of the two methods were similar, indicating that the most likely number of cases present in the United States is between 4 and 7 animals. Therefore, USDA concludes that the prevalence of the disease in the United States is less than 1 case per million adult cattle, based on an adult cattle population in this country of 42 million animals. The testing program is not part of U.S. food safety protections. The system of interlocking safeguards protects animal and public health. The most important safeguards are the removal of specified risk materials from the food supply, along with the Food and Drug Administration's (FDA) 1997 ruminant-to-ruminant feed ban. Science indicates that the longer the FDA's feed ban is in place, the lower the prevalence of BSE will be in this country. USDA will use the prevalence analysis, once it is peer-reviewed, and international standards set by the World Animal Health Organization, to design an ongoing BSE surveillance program for the United States. The data and analysis will also assist in making science-based policy and regulatory decisions related to the disease. USDA's enhanced BSE surveillance program followed the detection of BSE in an imported animal in December 2003. The target population of cattle tested included those animals where the disease is most likely to be found if it is present: non ambulatory cattle, cattle exhibiting signs of central nervous disorders or any other signs that may be associated with BSE, including emaciation or injury and dead cattle. Samples were drawn from more than 5,000 locations across the United States, including slaughter plants, renderers, farms, public health laboratories, veterinary diagnostic laboratories and salvage slaughter facilities. USDA is providing its analysis to outside experts for a scientific peer review and making it available to the public. USDA is confident the conclusions drawn regarding BSE prevalence in the United States are sound and scientifically credible. The analysis, along with a summary report on the BSE enhanced surveillance program, are available at http://www.aphis.usda.gov/newsroom/hot_issues/bse.shtml # USDA won't send mad cow experts for Canada probe Canada confirmed the case on Tuesday, in an older crossbreed beef cow. It was the country's sixth native-born case of the disease since 2003. Canada said the cow was born "well before" the 1997 ban on use of cattle protein in cattle feed, one of the major safeguards in North America against spread of the disease. The Canadian Food Inspection Agency invited USDA to take part in the investigation of the new case. "Based on our confidence of the food safety measures in place in Canada and our previous audits of the system, we have determined that it is not necessary to send any U.S. experts to participate in this epidemiological investigation at this time," said USDA chief veterinarian John Clifford in a statement. Clifford said "we do not expect that this latest case would cause any disruption in our trade in beef or beef products from Canada." Canada opened its border last week to all U.S. cattle. The United States accepts imports of younger cattle and beef from cattle 30 months or younger. A ranchers' group has waged a battle in court to prevent USDA from broadening its list of allowable imports. © Reuters 2006. All Rights Reserved. http://ca.today.reuters.com/news/newsArticle.aspx?type=domesticNews&storyID=2006-07-06T155645Z_01_N06191558_RTRIDST_0_CANADA-MADCOW-USA-COL.XML https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument 03-025IF 03-025IF-631 Linda A. Detwiler [PDF] http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf Specified Risk Materials (SRMs) I am in full support of the interim final rule which prohibits SRMs from being included in food for human consumption. In addition to the list of tissues published in this rule, I am requesting that additional tissues be added to the list. These would include dura ("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus to rectum). The scientific justification is provided below. THESE SRMs should also be prohibited from ANY FDA regulated food or product intended for human consumption, including but not limited to flavorings, extracts, etc. ... Dr. Linda Detwiler comments in full; http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA) Report The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003. The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties. A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries. EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases. Publication date: 20 August 2004 http://www.efsa.eu.int/science/tse_assessments/gbr_assessments/573_it.html TSS
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