Itchmo is liveblogging the 4pm Eastern FDA press conference. We will correct spelling and grammar errors after the live event concludes. This is not a transcript, but a report of the event.
Conference has ended. See our report after the jump. Or read our summary.
At the FDA Press Conference will be:
Julie Zawisza introduces speakers
Turns over to Acheson. wants to go over old ground to make sure we are on the same page– covers 5 topics
1) reiterate the whole story over wheat gluten
2) talk about expanded recall of Menu foods
3) human health impact
4) discover a strategy
5) mention where we are in investigation in China
1) when wheat gluten comes in, it can either end up in pet food or human food system. all of the contaminated products ended up in pet food system. this situation come to our attention with sick and dying pets. the problem was identified as wheat gluten and the wheat gluten was found to have melamine and the melamine related compound. once we found that melamine was found, we investigated the human food supply. and we have found no evidence and there has been none of that in the human food chain or as an ingredient in the human food chain. none of the cont. wheat gluten ended up in the human supply.
-portion went into hog and poultry feed- but none of this entered in the human food supply
-all of wheat gluten and rice protein concentrate has been in the pet food track and there has been no cross contamination
2) Menu foods has expanded their recall- belief is that there is a cross-contamination- check their website
3) human health impact: only connection with human food when some of the pet food has been used as human food. our current belief that threat to humans is extremely low and it is unlikely
low because: levels of melamine and dilution effect (when the cont. wheat gluten comes in the country, only small prop contains melamine — 5-8% is wheat gluten and wheat gluten is not sole ingredient in pet food so it is further diluted) when feeding to hogs and chickens, only a small part is fed to those animals
-the small portion of the meat that is on the market will potentially carry low levels of melamine and pork and poultry only is a small portion of a human’s diet.
results in a dramatic dilution of human contamination– highly unlikely that there will be a human illness
Clarification of 1st point: pet food being used as human food– not saying that pet foods is part of human diet– where it ended up in poultry and hogs and that’s how it became human food.
4) proactive strategy: 2 key elements: 1. what we are doing with imports: FDA is working with customs and has an import alert that focuses on protein concentrate of vegetable origin from China- held at the border and must be considered to be safe to proceed- preventing any further imports of cont. protein concentrate of veg. origin
2. domestic front: govts and agencies are investigating industries- raising the awareness of manuf. of their supply chain and if they have received ingred. from China and haven’t been used, they have been tested. this just begin this week. to date, there have been no results from that.
tested 700 samples that were either finished pet food or ingredients– of 700, approx. 400 samples tested positive for melamine. some were same samples from multiple lots- 300 have been negative. all positive came from the 2 companies we know about it. we have tracked all of the positive samples and we already been getting negative results. those numbers will continue to expand with the coming weeks.
5) where we are in China: the HHS/FDA team is on the ground in China and working with the govt for the invest. doesn’t want to go into specifics.
Back to Julie: Q and A period:
1) Abigail Goldman- LA Times
Q:Can you confirm an arrest in China? And also if ingredients are mislabeled when coming across?
A: question should be directed to Chinese authorities
Michael rogers answers if fraudulently labeled, we are not going to know about it- but if we find out, we will investigate.
Q:is that the situation that happened here?
A: No evidence that that is going on.
2) Boston Globe
Q: are other industries affected and what has been found with invest.
A: we are not in position to answer anything with investigation
Q: can you say that for sure that all melamine has been found and that it has reached the end of the supply?
A: confident that invest of pet food has been exhausted and we have the domestic assignment- getting out ahead of the curve and looking in other areas even though there is no evidence
Q: the wheat gluten went into baby food? have you been looking into baby food?
A: wheat gluten and rice protein goes in many foods but we have traced and there is no evidence that it went in baby food or other food and the only way was with animals
Q: when sending out invest. out for manufacturers that are invest for cont wheat gluten, where are they going to?
A: we are going to pet food manuf and human food manuf.
5) ABC News
Q: these cont lots didn’t get in the human food chain? how long has this been going on? How do we not know that it has happened a year and a half ago? Any poultry #s? Why is melamine okay to be in human food and not pet food?
A: We don’t have samples from last year, so we can’t rule it out. we can speculate for hours and how long this has been going on but bottom line, we don’t know. The dilution factor explains why it’s okay in the human food- the pets are eating the most contaminated part of this thing and eating the melamine and melamine compounds. only portions of pet food is being fed to the hogs and that is what is in the hog meal- hogs and chickens have been physically fine. further, if there is any in the hogs, the amount that is consumed by human is only a small portion of the daily diet. Poultry numbers — the same numbers that were outlined in Tues are the same- 2.7 million that were in Indiana and 100,000 breeder birds that are still on the farm
-in regards to the past, we don’t know for certain. we have looked at the incoming shipments for the two importers that we have had problems and we have looked into 2006 and saw where that material went to and it all went into the pet food and not into the human
6) USA Today:
Q: Smartpak recall? can you elaborate on that? the product doesn’t say that it has any protein concentrate from china
A: the product did contain rice protein concentrate that did have melamine in it– there was probably cross contamination from manuf
Q: 92 lots were negative?
A: 394 or so positive test results- we don’t have the negative results
7) ABC NEWS
Q: any comments that the Chinese would label ingredients as non-food products instead of food products
A: we need to see what the invest come up in China- clearly there are a # of reports but we need to wait until we get the facts and then respond to it. this whole episode raises questions.
Q: what does cross contamination mean? some vets have said that pets have died from cross-contamination?
A: cross contamination with e.coli can lead to human illness — i don’t have the specific levels that they found- based on that, they decided to do a recall. how they cross-contam. i don’t know.
Q: you are implying that it is a small amount. should we worry about human food?
A: cross contamination doesn’t specify quantity- they may just be doing this to be proactive and cautious
Q: any contaminated pork and poultry on market
A: No. for the poultry, 2.7 million- chickens had gone to slaughter — speaking of the dilution factor, there is no reason to believe those animals are any danger to public– of 6,000 swines on farms- about 300, went to slaughter– no risk to public health
Q: do you believe that there is any meat that has been contaminated with the feed?
A: No, none on the market
Q: no recall?
A: yes, no recall.
Q: levels of melamine? confident that melamine that caused pets to get sick and die?
A: varied to 0.2-8% of the ingredient. Yes, melamine alone isn’t toxic unless you feed in high doses. The discovery is that melamine compounds (cyanuric acid) and melamine when put together- it causes crystals in the kidney and leads to kidney failure.
Q: how many investigators in China and will you send more?
A: no, can’t answer that
Q: the FDA had gotten a report of about 2,000 cats and 2,000 dogs deaths. any updates on numbers?
A: no new numbers from that- we have to tally the #s- we have more phone calls then we are able to log in the system. next press conference, we can update #s.
Michael Rogers — agency has received more than 17,000 calls- our prelim. review of those, as many as 50% alleged pet deaths from those calls- this is not definitive proof
12) Dow Jones
Q: pork and poultry on the market- is it because that it is not on the market because it’s already been eaten? how about frozen products?
A: invest is quite active- the farms that we mentioned that we are aware of and there is control- the pet food trace back is winding down- through that process, we became aware it becoming into animal food– there are still animals resident on those farms and local actions are preventing them from moving to slaughter. we have no reason to believe that there is any risk to the public.
Q: 3 mil chicken that were slaughtered in Feb– your belief that they have already been consumed by the public?
A: there is no evidence of any harm from chicken or pork
13) NY Times
Q: about proactive invest? how have you determined which manufact. facilities to visit?
A: based on comp reg and our records, who does what and with ingredients- that is what we used to do invest- use local and state invest and they know who to visit- based on data of what ingreds go to which manu
Q: how many? how long will it take?
A: 100- we’ll keep on doing this until we have our arms around it.
14) Balt Sun
Q: found any melamine or related compounds in other veg products? and whether you have id’d any other importers that have received cont.
A: in US, we have only found in wheat gluten and in rice protein conct. We only have 2. Corn gluten was found in S. Africa. Can we rule any ingreds out? No. But, we haven’t found in other ingreds. To date, all of the positive results have been linked to the 2 companies
Q: import alert? looking at the documents, there were 3 separate import alerts (2 were for the 2 Chinese companies)– when I called the FDA, there was an ban on those 2 Chinese companies) but then they were saying that they were detained and not banned
A: initially, we were just focused on 2 suspects and now, the agency has taken a more widespread approach- these products are stopped at the border for 100% review- the present import alert (the company wide alert) is posted on the FDA website of what firms need to do to go through this process
Q: wheat gluten was labeled was wheat gluten- but there are reports that it wasn’t labeled as wheat gluten and that it went through a textile company
A: as we aware, it was labeled as wheat gluten- part of the confusion is because the Chinese exporter exports other things besides wheat gluten and they also do export textile company- but the wheat gluten was labeled as wheat gluten- we don’t have records of what ingredients are labeled
16) Tribune Media Services
Q: going back to 2006, it was said that melamine was found in pet food supply. then has this been affecting our pets for a very long time? if there is any question or doubt, why isn’t there a ban on all of these products?
A: to clarify the 2006, our invests of imported product involved 2 aspects: testing and tracing in where that product can be used. Testing: some of the product in 2007 and later 2006 was positive for mela and mel compounds. with records we trace back, where did that product go? it went into pet food and not human food. and if there were positive before late 2006, we don’t know because we don’t have samples. it didn’t make pets as sick before late 2006.
Q: so pets have been affected by this in an undescribed way for a long time?
A: certainly possible. in regards to the ban, many exporters do not have melamine in their product. we want to stop those that have contaminated ingredients- we want to filter, examine and invest everything.
Q: are you confident that it is 100% fool proof
A: nothing is 100% fool proof
Q: did any of the contaminated feed go to any other animals besides chickens and swines? # of Farms? once the pet food is recalled many owners started cooking with chicken and they are worried that they are feeding cont. chicken?
A: no evidence that it went anywhere else. # of farms- 30 poultry related farms, 8 swine related farms. concerns of pet owners that are preparing food at home — there is no indication that more pets are susceptible to melamine- we still don’t understand how this syndrome is affecting animals. we don’t recommend pet owners prepare their own pet foods at least over a long time. pet food meets nutritional needs and are balanced. if just feeding one ingredient is not in the best interest of the pet.
18) Washington Post
Q: if this had occurred in human food, there would be a case control study early on how strong the relationship would have been between the illness? has there been any log in the vet world so we can get some sense of how much the dosage and other effects?
A: no equivalent to the EIS in the vet world. we have been in contact with the AVMA and lab diagnosticians that have seen a lot of these cases. the correlation was so strong that it doesn’t require a case controlled study. we know what products were causing illnesses and deaths. we are trying to understand the dosage. Some of the cases varied and the highest i heard was 9%. colleges are trying to conduct studies and understand better the melamine and cyanuric acid and some of the other components that we have found in the wheat gluten and rice protein.
Q: having a hard time understanding that such a small amount can cause so much damage?
A: in a sample of wheat gluten, in some there were cases of 8% melamine and some had .2%- the contaminated wheat gluten was used in varying portions to make pet food. it varied in portions. 5-10% of pet food is wheat gluten. no specific number
Q: are you looking at other poss. contaminants? is there something else that caused this.
A: no, there is no evidence of other contaminants. we don’t believe the melamine alone caused this- it was the mel and the mel compound that forms crystals in kidneys. a lot of questions that we don’t have answers to.
Q: since you’ve put the import restrictions, you’ve done 700 tests and 394 positive?
A: 700 samples are not from the import alone- they are the total # of tests we have done. that’s everything. all of the positive has been related.
q: is this a limited problem?
A: we would be complacent if we didn’t further investigate
21) USA Today
Q: Can FDA rule out other cross-contamination?
A: I don’t quite understand the ?.
Q: If other products were cross-contaminated- can we rule that out in other foods?
A: all of the cont wheat gluten and rice protein cont has only gone into pet food and not into the human food. even if there was cross-contamination, it would be mute because there was no cont. wheat gluten/rice protein in human food supply. we can’t rule out cross- cont.- we are always on the look out for cross cont- nothing has entered into the human food supply as we know it.
everything that we have investigated, we have not found any cont in human food supply.
End of Press Conference