From: Robin Burton [burton@mail.agri.state.oh.us] Sent: Friday, May 27, 2005 3:44 PM To: Dockets, FDA Subject: Docket No.2000N-0504 Ohio Response SE Prevention-Shell Eggs-Pullets -----Original Message----- From: Robin Burton [mailto:burton@mail.agri.state.oh.us] Sent: Friday, May 27, 2005 2:41 PM To: 'ericging@vet.upenn.edu' Cc: 'Dr. David Glauer'; 'Jim Chakeres'; 'dcastellan@cdfa.ca.gov' Subject: Ohio Pullet SE Information The following is Ohio's response to questions posed by FDA in Docket No. 2000N-5040, which extended the comment period on draft regulations involving the prevention of SE in shell eggs during production. 1. How many pullet growing facilities/producers are there in Ohio? There are two types of "pullet" facilities in Ohio; "breeder" pullets and "layer" pullets. Only one producer in Ohio maintains a "breeder" pullet facility. There are an estimated 30,000,000 layer birds in Ohio, and an estimated 10,000,000 pullets. There are approximately 315 layer producers participating in the Ohio Egg Quality Assurance Program, and 102 pullet growers. We estimated these producers to represent 90% of the layers and growers in Ohio. There is about a 1 to 3 ratio of "pullet growers" to layer producers. These producers maintain anywhere from 1 to 6 barns, housing anywhere from 30,000 to 150,000 birds per barn. A majority of Ohio's producers, at least 90% require contract growers to participate in the Ohio Egg Quality Assurance Program. 2. What percentage of pullet growers are under programs aimed at preventing SE monitored chicks from becoming infected by SE during pullet rearing time? See above response 3. Does the Ohio Egg Quality Assurance Program include provision to prevent SE monitored chicks from becoming infected during pullet rearing time. "Pullet" growers participating in the Ohio Egg Quality Assurance Program have in place the same controls as those of layer facilities. They maintain a rodent and insect control program, dry and wet cleaning operating procedures and environmental testing at 8-12 weeks of age, prior to placement in a layer house. A positive environmental sample results in mandatory wet cleaning and disinfection of the pullet house prior to repopulation, and requires monitoring/testing of the birds in the subsequent layer house at 29-31 weeks and again at 44-46 weeks, and then 2-4 weeks prior to depopulation, as required of all layers. Most producers have chosen not to populate a layer facility with "monitored pullets". Very few Ohio pullet samples test positive for SE. It is a rare occurrence to have a positive pullet environmental test. This is most likely due to the stringent NPIP SE monitored program requirements mandated for replacement layer birds. Testing follows the same methods used under OEQAP testing and is conducted by the Ohio Department of Agriculture, Animal Disease Diagnostic Laboratory, which is accredited by AAVLD. Many participating producers do in fact utilize vaccination as PART of their SE control program. Utilization of vaccine appears to becoming more popular all the time. Vaccination of pullets takes place approximately at 14 days, 45 days and again at 75 days. There are variations on this time frame from producer to producer depending on specific flock health management practices of individual producers. We estimate that over 60% of the pullet growers utilize vaccination programs. 4. What are the common cleaning and disinfection practices? Participating pullet growers follow the same cleaning and disinfection procedures required under the Ohio Egg Quality Assurance Program for layer producers. Environmentally positive barns require complete wet clean with disinfection. 5. Are measures taken to reduce the prevalence of rodents and pests in pullet houses? Participating pullet growers follow the same requirements for control of rodents, flies and pests as directed under The Ohio Egg Quality Assurance Program for layer producers. It is significant to note that large growers, those with 100,000 or more birds, are required under Ohio law to obtain and maintain a Large Animal Permit from the Ohio Department of Agriculture. Permit requirements include manure management, water quality, mortality disposal, rodent and pest control. Many of Ohio's growers maintain these required permits. Any "Egg Safety" program will have to dovetail with the environmental requirements placed on "large animal" operations. The other concern or issue the Ohio Department of Agriculture has with FDA regulation of pullets, is the fact that "pullets" are not eggs. Breeder pullets are governed under NPIP, and in Ohio, pullet growers follow same/similar risk reduction practices as those followed by layer producers. FDA will be substantially increasing the funding and resources needed to "regulate" pullet growers, not to mention the dramatic increase in testing expected by including "pullet" growers in the "EGG" safety regulations. Where will the funding come from to support these additional efforts? With USDA involvement already established with NPIP, would it not make more sense to place this regulatory responsibility with USDA NPIP. NPIP, FSIS, APHIS and the Ohio Department of Agriculture Large Livestock Permitting and OEQAP) already have active involvement with Ohio poultry producers. Why add a whole additional layer of regulatory oversight with yet another agency? Would it not be more practical and cost efficient to reorganize or adjust current activities to incorporate any additional oversight or regulation that may be necessary for layers or pullet growers with agencies already present in these facilities? This email was sent from the Ohio Department of Agriculture.