MR. JIM ROGERS: Hello, everyone. This is Jim Rogers with the Animal and Plant Health Inspection Service's Legislative and Public Affairs Office. First off, I want to thank you for your patience and apologize for the delay. If you've ever called a phone company, I think you'll all understand.

We have with us today Chief Veterinarian Dr. John Clifford, and he is going to talk about the proposed rule that will expand the minimal risk regulations for importation.

DR. JOHN CLIFFORD: Thank you, Jim. Good afternoon and thank you for joining today's call about USDA's proposal to expand the list of allowable imports from countries recognized as presenting a minimal risk of introducing bovine spongiform encephalopathy, or BSE.

This proposed rule was put on public display today and we expect it to be published in the Federal Register on January 9. In January 2005, USDA published a final rule that established conditions for the importation of live cattle under 30 months of age and certain other commodities from regions with effective BSE prevention and detection measures.

That rule also designated Canada as the first minimal-risk country recognized by USDA. This current proposal would expand the scope of the 2005 rule to facilitate fair, science-based trade, consistent with international standards as defined by the World Organization for Animal Health, also known as the OIE.

Specifically, the rule proposes allowing the importation of: live bovines for any use born on or after March 1, 1999 -- the date determined by APHIS to be the date of effective enforcement of the ruminant-to-ruminant feed ban in Canada; blood and blood products derived from bovines, collected under certain conditions; and casings and part of the small intestines derived from bovines.

The public comment period on these proposed actions opens January 9, 2007, and will close on March 12, 2007. We encourage the public to be a part of our decision-making process by providing feedback through submission of public comments.

International standards as defined by the OIE served as our reference in developing the proposed actions.

The OIE provides standards, guidelines, and recommendations to be used by national veterinary authorities to prevent the introduction of animal diseases such as BSE while avoiding unjustified trade barriers. In keeping with these standards, we conducted a thorough risk assessment and found that the risk presented by allowing these additional commodities from Canada is minimal. Our risk assessment included careful consideration of the entire risk pathway, all of the steps in both Canada and the United States that must occur for BSE to spread to an animal here in the United States.

If an infected cow from Canada were to be imported into the United States, in order for that bovine to transmit infection to a U.S. cow a series of additional safeguards would have to fail or be breached. Even if by small chance BSE-infected material were to make it past the first mitigation, it is highly unlikely that the material would eventually infect a U.S. animal.

It is important to remember that these individual safeguards or steps in the risk pathway should not be considered in isolation. The impact of any specific step depends on its relationship to the others in the sequence. In other words, none of the steps should be considered by itself to represent the entire risk.

As part of the risk assessment, we estimated the prevalence of BSE and the standing adult cattle population of Canada with the same methods that we recently used to estimate the prevalence of BSE in the United States. This estimate incorporating information about the expected effects of the feed ban is 6.8 infected animals per 10 million adult cattle.

We then used this current estimate of prevalence to help assess the likelihood that BSE would be introduced or released over an extended period of time. We chose to evaluate what could happen over the next 20 years, assuming the proposed rule would apply into the foreseeable future. First, we looked at the most likely scenario, given that Canada has had a feed ban in place since 1997, and evidence indicates that the implementation of the feed ban results in decreasing BSE prevalence. The most likely scenario is that BSE prevalence in Canada will continue to decrease over the next 20 years.

This decrease, combined with the mitigative effects of our import requirements and the young age of animals at the time of import, would continuously decrease the possibility that infected animals would be imported over the 20-year period.

Under this scenario, the likelihood of BSE exposure and establishment in the U.S. cattle population, as a consequence of importing infected Canadian cattle, is negligible.

We then considered other less-likely scenarios that may overestimate the overall risk. In these less-likely scenarios we assumed that BSE prevalence in Canada would remain constant during the next 20 years. This would mean the continued detection of infected animals born after the implementation of the feed ban and during the entire 20-year timeframe.

Even with these less-likely scenarios, our assessment indicates that BSE will not be spread or become established in the United States as a result of the proposal. Although our risk assessment was conducted to evaluate animal health risk, we did use one model in our assessment to also consider possible impacts on public health.

The results of this model indicated that these potential impacts are extremely low. As you know, public health in the United States is protected through slaughter practices, including the removal of specified risk materials, and the feed ban.

In conclusion, for all commodities considered under the current proposal, the risk of BSE-infectivity is negligible and the disease will not become established in the United States. This is true even if Canada identifies additional cases of BSE and even if an infected animal were to be imported to the United States.

Now let me take this opportunity to address any questions you may have about the BSE cases that have already been identified in Canada. From the time of detection of the first native case of BSE in Canada in 2003, nine cases of Canadian-born BSE-infected cattle have been identified. All these cases are considered in our prevalence estimate, but it is important to understand that the model used for that estimate is much broader than simply evaluating the number of cases detected.

Since the model incorporates a wide range of epidemiological information and assumptions, the identification of additional cases does not significantly impact the prevalence estimate. We recognize that three of these cases were born after the date proposed in our regulation as when the feed ban was effectively enforced. Let me say that these cases are not unexpected, nor does USDA consider such diagnoses in any way to undercut our conclusion that March 1, 1999, can be considered the date of effective enforcement of the feed ban in Canada.

Experience worldwide has demonstrated that even in countries with an effective feed ban in place, BSE has occurred in cattle born after the feed ban was implemented. However, such isolated incidents do not contribute to further significant spread of BSE, especially when considered in light of the series of risk mitigations in place.

I want to emphasize that our risk assessment considered the entire risk pathway, all the series of risk mitigations in place. The proposed requirement -- only allowing imports of live bovine born on or after March 1, 1999 -- is one step in the process that decreases the risk. It should not be interpreted as the only or the failsafe step in this process.

USDA is committed to ensuring that our regulatory approach keeps pace with the body of scientific knowledge about BSE. These proposed actions are an important move in our efforts to promote fair, science-based trade practices. I am confident in saying that we can take this next step while at the same time protecting American agriculture and maintaining confidence in the U.S. beef supply.

Thank you again for calling in, and I'll be happy to take your questions now.

MR. ROGERS: Operator, we're ready for the question and answer period.

OPERATOR: Thank you. If you would like to ask a question, please press *1. You will be announced prior to asking your question. Please announce your affiliation as well. Our first question comes from Pete Hisey. Your line is open, sir.

REPORTER: Hi. This is Pete Hisey at Meatingplace. My immediate question is, evidently Canada is about to introduce a stronger feed ban in July, and I'm curious why we didn't wait until after that ban takes effect to propose this rule.

DR. CLIFFORD: When we looked and did our risk assessment, we took the current measures that Canada had in place and be able to show that the risk is negligible. So that's why we didn't wait.

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Chuck Abbott.

(Pause, no audible response)

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Sally Schuff.

REPORTER: Yes. Thank you for taking my question. Dr. Clifford, I need clarification here on, you're saying that all cattle, breeding, slaughter, and beef and beef products from after March 1, 1999, will be eligible for import?

DR. CLIFFORD: Sally, that's correct. Now, one point of clarification: If this rule were to go into effect, any live animal coming into the U.S. would need to be born after March 1, 1999. Now this would allow the implementation of any aged beef allowed to be imported as long as it meets the conditions of the Food Safety and Inspection Service and SRM removal.

REPORTER: And any aged beef? The beef is not subject to the March 1?

DR. CLIFFORD: That's correct.

REPORTER: I see. Okay.

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Peter Shinn.

REPORTER: Yes. What's (unclear).

MR. ROGERS: Next question, please.

REPORTER: Gentlemen, I'm sorry. Can you hear me?

MR. ROGERS: Yes. Go ahead.

REPORTER: I'm just wondering what the timeline is for implementation. I know you've got public comments, and then what's the timeline after that for actually putting this in place?

DR. CLIFFORD: Well, as you know this is a proposed rule out for comment. We would -- after we receive those comments we will take careful consideration in putting together our response to those and see if we need to make any changes based upon those comments. So I can't give you a specific timeline at this point in time.

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Chris Clayton.

REPORTER: Dr. Clifford, real quick, first I wanted to clarify something you just said to Sally, because the news release I got seemed a little different. You said the beef product was not subject to the March 1, '99, age restriction, because the release I have states that it is.

DR. CLIFFORD: 'MRR2.' Basically this rule would -- for animals imported to the U.S., live animals, for breeding or for slaughter -- would be restricted to the March 1, 1999, date. Animals slaughtered in Canada and the importation of beef could be prior to that March 1 date.

REPORTER: And has USDA been given, I guess, any kind of assurance from our trading partners that, okay, you're going to import these animals, and if there is a case, that is not going to be something that would cause us to further restrict trade?

DR. CLIFFORD: Basically Chris, we've been in discussions with our trading partners. We notified them of this proposed rule. It is a 'proposed rule.' We're looking forward to the comments on this rule, and we would have further discussions on those issues with our trading partners. But I'd just like to say we would encourage all of our trading partners to follow international guidelines and standards and follow the science of this disease.

MR. ROGERS: Next question, please.

OPERATOR: Next question comes from Barbara Duckworth.

REPORTER: Yes. Hello. You have mentioned this March 1, 1999, date. What kind of age verification and identification will you require on the live animals?

DR. CLIFFORD: Basically with regards to the age we would require certification by Canadian officials based upon that date. Also as far as identification, each individual animal would be required to have an ID plus a permanent tattoo or other type of permanent marking that would be required.

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Daniel Goldstein.

REPORTER: Yes, hi, Doctor. Is the USDA saying that Canadian animals that are born before March 1, 1999, are not safe to import to the U.S.?

DR. CLIFFORD: Basically, what we're saying is, is based upon our assessment and analysis of when an effective feed ban went into place, the date of March 1, 1999, was determined. That was based upon Canada putting a feed ban in place at the same time the U.S. did. In August of '97 we looked at having six months of a practical implementation date, and then we added an additional year to that date for the normal marketing period where you would expect feed to be cycled through in the cattle in that system.

So basically there's where we came up with the year-and-a-half date. So it's not saying that cattle born prior to that are unsafe. It's just saying that we're looking at that as an effective feed ban date and we're just accepting live cattle after that date.

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Steve Kay.

REPORTER: Dr. Clifford, firstly, earlier you said that Canada had nine BSE cases from the first native case. Did you mean 8? I only have 8 listed.

DR. CLIFFORD: Canada actually has found 8 cases within Canada and the U.S. has found one case that --

REPORTER: Washington State case, okay.

MR. ROGERS: Next question, please.

REPORTER: Can I have a quick follow-up?

MR. ROGERS: Go ahead.

REPORTER: As you know, case number 4 and 5 were born after that March 1, 1999, date. They were both born in the year 2000. So some people would say that you've just kind of, on the back of an envelope, put six months plus one year, to use your words, and come up with a March 1 date. You know, what other justification can you explain to me as to why you chose that date?

DR. CLIFFORD: Well, the justifications that we made were based upon what I gave you. We have previously, under the minimal risk rule one that we came out with, we evaluated Canada's effective feed ban and determined that they had an effective feed ban during publication of that rule, and that was based upon our personal investigation and knowledge of that system and information that was provided to us.

They have the authority, they have the infrastructure, plus they've established our performance standards within that system to be able to effectively monitor that system, make sure there's appropriate training. As you know, with any type of system there's no such thing as 100 percent compliance.

And if we'll look throughout internationally we know that countries that have had other effective feed bans put in place will find case after that effective feed ban.

REPORTER: But does the rule address the fact that there were three cases, the latest being April 22, 2002, when there was a BSE case?

DR. CLIFFORD: There is, the rule takes into account that three cases occurred after that feed ban date, and again the risk -- when you look at these things you can't look at one particular issue. You have to look at it in total through all the mitigations, whether you're talking about SRM removal, to feed ban, to feed manufacturing, to rendering inactivation, to biological limitations. So you have to look at the whole system as a whole when you're looking at the level of risk. And we have found, based upon that risk assessment, when you look at this as a whole that the risk is extremely low.

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Chuck Abbott.

(Pause, no audible response)

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Christopher Doering.

REPORTER: Yes. I apologize if I jumped on late because I was having technical difficulty problems. Do you know when -- I know the comment period ends on the 12th of March, but when do you guys anticipate this may be actually be cleared, once you analyze comments?

DR. CLIFFORD: Again, I can't give you an exact date with that.

REPORTER: Is there a generalization as to --

DR. CLIFFORD: I wouldn't even want to generalize. There's a lot of factors here. It depends upon the number of comments, how extensive those comments are, and so forth. So we would not want to speculate about timeframe.

MR. ROGERS: Next question please.

REPORTER: Just to be clear, after the 1999 or March 1, 1999, number, there's been how many cases have been reported in Canada, three?

DR. CLIFFORD: There were three cases that have been found that were born after the feed ban.

REPORTER: And one of them was the Washington State cow that came --

DR. CLIFFORD: No, no. All three of those cases were found in Canada.

REPORTER: Okay, thank you.

DR. CLIFFORD: You're welcome.

MR. ROGERS: Operator?

OPERATOR: Yes, sir.

MR. ROGERS: I'm sorry, I should have noted this at the beginning. Let's just do one question with no follow-up. I believe we'll be doing questions for about five more minutes. Next question, please.

OPERATOR: Thank you. We do have a question again from Daniel Goldstein. Would you like to take that?

DR. CLIFFORD: Yes.

REPORTER: Thank you very much, Dr. Clifford, for taking my call again. You've also come up with the date of March 1999 for the effectiveness of the Canadian feed ban. Obviously the U.S. and Canada put their feed ban in effect about the same time. Is that also, in effect, also saying that the U.S. feed ban also became effective in 1999, not in 1997?

DR. CLIFFORD: Basically, what that date does is allow for -- in Canada we allowed for the six months of implementation for full implementation, and then for the feed in the system cycle out based upon the likelihood of that being cycled out within that year timeframe, with most cattle operations. That's where we came up with 1.5 year timeframe on the feed ban. Now, what countries applied to us is up to those countries. Again we implemented our feed ban, FDA did, at the same time Canada did, and I believe actually Canada has a date very close to ours for an effective feed ban date for the U.S.

MR. ROGERS: Next question, please.

OPERATOR: Our next question comes from Sally Schuff.

REPORTER: Yes, thanks again. My question is, from the news release it says just meat products. Are you talking about boneless or bone-in or both?

DR. CLIFFORD: Both.

REPORTER: Okay, thank you. And all ages again?

DR. CLIFFORD: For live animals they would have to be born after March 1, 1999. For meat products it would be all ages.

REPORTER: Thank you.

OPERATOR: Our next question comes from Pete Hisey.

REPORTER: Hi. It's Pete Hisey from Meatingplace again. Will anything be done to ensure no commingling in the case of exports to countries that accept our beef but do not accept Canadian beef?

DR. CLIFFORD: These animals would be identified with an ear tag, and then they would have permanent identification with regards to either a tattoo or other type of method such as branding.

MR. ROGERS: Next question, please.

OPERATOR: Thank you. If you would like to ask a question, once again please press *1.

MR. ROGERS: Operator, we'll take two more questions if anybody has any.

OPERATOR: Thank you. Once again, Chuck Abbott your line is open.

REPORTER: Hi. I'm going to try again with a different phone. You know, Dr. Clifford, we're going to make you walk that path one more time, which is: wouldn't, under the normal circumstances, wouldn't this sort of rule become final sometime in late summer? And secondly, are there any other countries out there other than Canada that might be in line to become minimal risk regions?

DR. CLIFFORD: As far as the first question, again I can't give you any timeframe. There's a lot of variables with regards to when this rule could become effective, and it's very important that we carefully consider all public comments on this rule and respond to those comments appropriately.

With regards to your question about other countries, we have had countries informally inquire about being looked at as a minimal risk country, but we've not had any formal request from any country at this time other than Canada.

MR. ROGERS: Operator, this is the last question.

OPERATOR: Thank you. Our last question comes from Barbara Duckworth.

REPORTER: Yes. This deals with bovines. Is there another rule coming for sheep and goats and deer?

DR. CLIFFORD: Actually deer would be excluded, I believe, from this rule. But with regards to sheep, yes, that would require future rulemaking.

MR. ROGERS: All right. I want to thank everyone for their patience once again, and of course we always appreciate your questions. For further information please check out our website at WWW.APHIS.USDA.GOV. Once again, thank you very much and have a nice day.

Operator, this concludes the call.