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From: TSS ()
Subject: BSE CANADA IMPORTANT NOTICE IMPORTANT NOTICE - Revised Policy Regarding Gelatin in Natural Health Products July 4, 2006
Date: July 6, 2006 at 1:30 pm PST

Electronic Bulletins

IMPORTANT NOTICE - Revised Policy Regarding Gelatin in Natural Health Products
Date: July 4, 2006

Subject: EFSA RISK ASSESSMENT FOR ONLY BSE by Bovine Vertebral Column including Dorsal Root Ganglia to humans
Date: June 16, 2006 at 8:54 am PST
Summary of Opinion 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


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.


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 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.


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 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.<<<


sample survey via oie for bse is about 400 test via 100 million cattle, if i am not mistaken. MOST countries that went by these OIE guidelines all eventually went down with BSE. ...TSS

THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they should do everyone a favor and dissolve there organization. ...


Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA


see full text ;

Revised Policy Regarding Gelatin in Natural Health Products
The gelatin used in formulating or encapsulating natural health products may be made from a variety of animal materials. Those products that have been licensed for sale by Health Canada are safe, but in order to further enhance the continued safety and quality of those products which contain gelatin made from the bones of the following animals : cattle, sheep, goat, deer, and elk, which are susceptible to Transmissible Spongiform Encephalopathy (TSE) diseases such as Bovine Spongiform Encephalopathy (BSE or Mad Cow Disease), the Natural Health Products Directorate (NHPD) has established some additional quality control requirements.

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
gelatin made of materials from animals that are not susceptible to TSEs (e.g. pig), or
gelatin made from the skin and hides of any animal.
Alternative Options

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

Evidence indicating that the alkaline process with the conditions specified below was followed in the making of the gelatin:

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

Other specific manufacturing information regarding measures taken to mitigate the risk of a causative agent of a TSE in the gelatin. Please note that the NHPD may require further information, including a risk assessment, in this instance.
Licensees and applicants 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 within the indicated timeframe.

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.

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


“ 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


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

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

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 Visit CPR on the web at

-- 30 --



WASHINGTON, D.C. – Following last week’s request that the Department of Agriculture withdraw its rule to reopen the Canadian border, Senator Tom Harkin (D-IA), joined by Senators Kent Conrad (D-ND), Tim Johnson (D-SD) and Ken Salazar (D-CO), today sent a letter to Agriculture Secretary Johanns detailing their concerns with the rule. The letter was sent to the secretary two days before his scheduled appearance before the Senate Agriculture, Nutrition and Forestry Committee, where Harkin is the ranking Democrat.

“There are very real concerns about USDA’s plan to open the Canadian border to live cattle and a broader range of beef products,” Harkin said. “My colleagues and I are strongly urging USDA and Secretary Johanns to withdraw the rule and address the shortcomings that exist. This issue deserves a proper and comprehensive solution.”

Harkin’s concerns center around how a country is categorized a “BSE minimal risk region,” and USDA’s departure from World Organization of Animal Health (OIE) standards that USDA has purported to follow. The rule appears to be narrowly focused on broadening trade with Canada rather than taking a comprehensive approach which should help reopen trade with all markets that have been closed to the U.S. following the December 2003 identification of a BSE-positive cow in Washington state. By choosing less protective safeguards than the OIE standards, USDA is creating the risk that other countries with a higher prevalence of BSE than Canada may try to get their products into the U.S. Harkin is concerned that imports from Canada under USDA’s current plan would potentially jeopardize U.S. efforts to restore beef trade with countries like Japan and South Korea—who are likely to require stricter safeguards than the U.S. is requiring of Canada.

The letter is included below:

February 1, 2005

Dear Secretary Johanns:

At your confirmation hearing, several members of the Senate Committee on Agriculture, Nutrition and Forestry expressed concern about the final rule published in the January 4, 2005, Federal Register (Volume 70, Number 2) regarding measures to define a Bovine Spongiform Encephalopathy (BSE) Minimal Risk Region and to allow for the expansion of beef and live cattle trade with Canada.

The U.S. Department of Agriculture (USDA) is to be commended for taking the lead worldwide in efforts to put the Office International des Epizootics’ (OIE) guidelines for BSE minimal risk into practice. Defining and implementing a global minimal risk standard for safely resuming trade with countries or regions that have experienced cases of BSE is critical to facilitating trade worldwide and restoring lost U.S. beef markets.

Unfortunately, USDA’s final rule has serious shortcomings that necessitate the rule’s revision–even if that means a delay in USDA’s March 7th effective date. The rule appears to be narrowly focused upon broadening trade with Canada rather than representing a comprehensive approach to trade under a minimal BSE risk framework. Two elements are critical to efforts to restore and expand beef trade: protecting our domestic food, feed, and livestock supply from BSE, and fostering international agreement on a BSE minimal risk policy, a benefit of which would be facilitating the restoration of safe two-way beef trade with key trading partners such as Japan and South Korea.

To protect our domestic food, feed, and livestock supply, we must make certain that all necessary steps are taken to ensure that beef products and live animals imported from countries, such as Canada or Japan, known to have BSE are free of the infective prion, and that our domestic safeguards against BSE are effective. Restoring trade in light of BSE can only be achieved by seeking scientifically-based consensus among our trading partners regarding the conditions under which countries or regions can be classified as minimal risk and the products that are safe to trade with them.

Currently, the only international standards that have widespread agreement are those adopted by the OIE. While USDA purports to rely upon OIE standards as a reference in its final rule, the reality is that USDA has chosen weaker standards than the OIE. This raises questions about whether USDA’s standards are adequate to protect our food, feed, and livestock in fact and in the minds of consumers, producers, and our trading partners.

USDA’s final rule, establishes a “minimal risk region” category for BSE that USDA says is modeled after the OIE minimal risk guidelines. The OIE minimal risk guidelines are part of the larger OIE guidance regarding classifying the BSE risk of regions and countries. OIE BSE guidelines are intended to allow for countries or regions that have experienced BSE cases to continue safe trade of beef products and live cattle. The guidelines reflect the consensus of world animal health experts regarding what steps importing countries should take to protect themselves when trading with other countries that have, or may have, BSE.

USDA’s final rule disregards key OIE protections against BSE that serve as linchpins for the guidelines. The OIE guidelines contain three stringent requirements with crucial time-sensitive factors. The first is that an effectively enforced ruminant-to-ruminant feed ban must have been in place for at least eight years. The second is that a requirement for the mandatory reporting and investigation of cattle displaying clinical signs of BSE must have been in place at least seven years. The third is that a well-implemented education and surveillance program to assure effective monitoring of BSE must have been in place for at least seven years. These requirements are central to assessing a country or region’s BSE risk, yet USDA’s final rule adopts less stringent measures in all three of these areas. USDA is essentially saying that USDA reserves the right to review a country’s anti-BSE measures, ignore the science-based OIE standards, and instead create its own standards.

In the final rule, USDA requires a feed ban that is equivalent to measures taken in the U.S. but omits the requirement that a feed ban be in place and effectively enforced for eight years. The passage of several years following the effective implementation of a feed ban is required to ensure that younger cattle have not been exposed to potentially contaminated feed.

In the final rule, USDA also does not specify a seven-year requirement for mandatory reporting of cattle exhibiting clinical signs of BSE nor does it specify the time requirement or factors for determining the effectiveness of a country’s surveillance system, both of which are required by the OIE. Together, these two OIE measures are intended to ensure it is possible to accurately assess the prevalence of BSE in a country. Without an accurate estimate of prevalence there is no good way to assess a country’s risk of BSE. In disregarding these OIE requirements, USDA is creating the risk that USDA will underestimate the risk of BSE in other countries because of those countries’ inadequate reporting and surveillance systems.

Under a strict reading of the OIE guidelines, for instance, Canada could be considered a country at moderate rather than minimal risk of BSE. This classification, of course, would further intensify the BSE mitigation measures the OIE would recommend for Canada to ensure the safety of Canadian export products. In fact, USDA’s departures from the OIE guidelines noted above seem specifically directed at avoiding those OIE criteria that would place Canada in a moderate risk category. The two most significant factors that would place Canada into a moderate risk category are that Canada’s feed ban has not been in place for eight years or proven to be effective, and that the ultimate prevalence of BSE in Canada’s cattle population is not known with confidence.

While Canada has had a ruminant-to-ruminant feed ban in place for seven years, it appears it was not effective throughout that period as required by the OIE. FDA has raised concerns in issuing import alerts concerning the presence of animal tissue in vegetable feed products that Canadian feed companies have attempted to export to the United States. Additionally, Canada has proposed new regulations that are about to go into effect that would strengthen its feed rules by barring the use of specified risk materials (SRMs) in any animal feed or in fertilizer–suggesting that Canada itself has concerns about the effectiveness of its current feed rules.

As for the prevalence of BSE in Canada, there will be no authoritative estimates of Canadian BSE prevalence until Canada has completed at least one cycle of its enhanced BSE testing program. Based on Canadian testing results so far, it is possible that Canada may ultimately be shown to have a BSE prevalence rate that is, in fact, too high to meet the OIE’s minimum risk standard of two cases per million cattle.

Especially since BSE-infected cattle continue to be discovered in Canada, it is important that USDA resolve these issues prior to designating Canada a minimal risk country. USDA has failed to show why it should not adopt the OIE guidelines in full. USDA’s departures from OIE guidelines appear to create an increased risk that BSE-infected products or animals will be imported into the United States–whether from Canada or some other country seeking minimal risk status under USDA’s final rule at a later time.

More specifically, we are concerned that in its proposed rule, USDA proposes backing away from the 30-month age limit on beef products and the requirement for segregated processing of cattle over 30-months. A sound public health approach dictates cutting off all possible routes by which material from infected cattle could enter the U.S. food and feed supply. USDA’s final rule expresses a belief that removal of SRM’s from cattle over 30 months old during slaughter is sufficient to manage BSE risk. However, given the unknowns about BSE, and the unknowns about the prevalence of BSE in Canada and the effectiveness of Canada’s feed ban, it is not clear that SRM removal is sufficient. Furthermore, Canada has not universally adopted the U.S. ban on non-ambulatory cattle slaughtered for human consumption.

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.

Restarting trade among countries that have experienced BSE cases within their borders is no easy task, particularly when it comes to large beef exporting nations such as the United States and Canada. The USDA approach seems to have been to focus almost exclusively on restarting trade with Canada, rather than developing a comprehensive approach to address BSE risk globally and reopen overseas beef markets currently closed to the United States. Currently, the United States seems to be headed towards at least two different sets of minimum risk standards–one for imports into the United States from Canada, and one for exports of products from the United States to Japan. The United States will allow live cattle under 30 months of age and beef from cattle of any age to enter the United States, while Japan, according to news reports, is considering allowing only beef from cattle 20 months and younger to enter Japan. Given that BSE has been found in cattle between the ages of 20 and 30 months, it is not clear why there should be a more protective standard for Japanese consumers than for U.S. consumers.

Of great concern is the very real danger that allowing imports of Canadian beef products from cattle over 30 months of age and live cattle under 30 months of age will impair our efforts to achieve resolution of beef trade issues with countries such as Japan. The key to reopening these markets to U.S. products is to restore their governments’ and consumers’ confidence in the safety of our beef by demonstrating the robustness of our safeguards against BSE. To establish guidelines that are demonstrably inferior to internationally recommended guidelines seems likely to frustrate that objective. A far better approach would be to work with our major beef trading partners using the OIE guidelines to develop a common framework for deciding whether a country has minimal risk status, and what products are safe to export and import from that country. Not only would this approach lead to common standards for risk determinations and risk mitigation measures as envisioned by the OIE guidelines, it would minimize the economic dislocations that would likely be caused by USDA’s piecemeal approach to reopening lost beef trade market by market.

In closing, we believe the USDA’s final rule, as currently written, would place United States consumers, producers, beef industry and livestock at unnecessary risk, and urge you to withdraw the rule for revision so that these concerns may be addressed. Thank you.


________________________________ ________________________________

Tom Harkin Kent Conrad

________________________________ ________________________________

Tim Johnson Ken Salazar

USDA Inspector General Analysis Supports Harkin Recommendations to Strengthen USDA Initiatives

WASHINGTON, DC – Senator Tom Harkin today said he is pleased that the U.S. Department of Agriculture (USDA) has responded to recommendations he and others have made for strengthening USDA’s protections against bovine spongiform encephalopathy (BSE) but is concerned that significant shortcomings in the anti-BSE efforts still exist. Harkin’s comments were based on findings within a USDA Inspector General (OIG) report to be released later today on BSE surveillance efforts. Harkin emphasized that consumers should not have concerns about the safety of beef, but that USDA must strengthen its anti-BSE efforts to head off potential BSE problems in the United States and to shore up consumer confidence both here and in foreign markets.

“This report finds that USDA has made some progress in improving America’s anti-BSE firewalls,” Harkin said. “Yet a good deal more must be done. The OIG identified shortcomings throughout USDA's anti-BSE program. I urge USDA to expedite implementation of OIG’s recommendations in order to assure our trading partners and consumers around the world that U.S. beef is safe.”

Some of the key findings in the 118-page report include:

Sampling is Poor: Since USDA’s expanded testing and surveillance program is voluntary, it is unclear whether its sampling design was sufficient to make conclusions about the prevalence of BSE in the United States. The report emphasized the need to ensure that limitations in the testing and surveillance program are apparent to the public given that industry stakeholders could misinterpret USDA’s conclusions.

“Since USDA’s testing is voluntary, we still cannot demonstrate with certainty that the incidence of BSE is extremely low in U.S. cattle, which we believe to be the case,” Harkin said. “USDA should design its program to ensure it is truly representative of U.S. cattle at risk for BSE. Presently, it does not.”

Potential Problems in Tracking the Disease: OIG has found that USDA has not maintained a complete database of all meat renderers so that so that the Department can trace any possible infection back to its origins. This information is also needed to aid proper functioning of the proposed national animal identification system.

The OIG listed numerous instances when USDA had difficulties tracing the origin and age of cattle. An animal ID system would resolve these issues immediately.

“An animal identification program could help solve many of the current problems this report identified in USDA’s anti-BSE efforts,” said Harkin. “Unfortunately, the administration has dragged its feet on this and lacks a clear plan for moving forward with an effective, feasible and practical system for producers.”

20,000 Clinically Normal Cattle Sample Poorly Done: USDA did not conduct tests of clinically normal aged cattle in a statistically valid manner. This is important because countries in Europe have had a small number of cases with BSE from these clinically normal aged cattle. Harkin has written letters to USDA requesting random testing among cattle born around the time of the feed ban --the key safeguard for managing BSE.

“The OIG found that USDA put forth a half-hearted effort to conduct this testing, and focused on younger cattle -- guaranteeing their findings would be largely meaningless,” Harkin said. “I am disappointed in USDA’s efforts in testing these animals and maintain that their testing should be a critical component of the Department’s surveillance program.”

Problems in demonstrating removal of specified risk materials (SRM) from food: OIG could not determine if SRM procedures were followed due to a lack of record keeping at many establishments. OIG also found that inspectors responsible for ensuring proper SRM removal were not always experienced to identify problems. This limits their ability to know when requirements for removing risk materials are not met.

“Removing risk materials is the primary way to prevent the introduction of BSE into the food supply – and this is the key part of the protections that consumers are counting on,” Harkin said. “It is vital that these shortfalls are corrected immediately.”


Release No. 0143.06
Ed Loyd (202) 720-4623
Jim Rogers (202) 690-4755


WASHINGTON, April 28, 2006-Agriculture Secretary Mike Johanns today announced USDA's estimate of the prevalence of bovine spongiform encephalopathy (BSE) in the United States.

"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


USDA won't send mad cow experts for Canada probe
Thu Jul 6, 2006 11:56 AM EDT

WASHINGTON (Reuters) - The U.S. Agriculture Department said on Thursday it will not send any experts to take part in Canada's investigation of its latest case of mad cow disease, saying it was confident in Canada's food safety measures.

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.

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle

03-025IF 03-025IF-631 Linda A. Detwiler [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;

EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)
Last updated: 19 July 2005
Adopted July 2004 (Question N° EFSA-Q-2003-083)

Summary of the Scientific 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


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