Kenneth L Klippen - Comment

Sparboe Farms, a family farm since 1954 producing eggs in Minnesota, Iowa, and Colorado appreciates this opportunity to comment on the Guidance Document for the FDA Egg Safety Rule, as found in the Federal Register /Vol. 75, No. 155 /Thursday, August 12, 2010 / 48973 http://edocket.access.gpo.gov/2010/pdf/2010-19905.pdf Previously in the Federal Register of July 9, 2009 (74 FR 33030), FDA issued the final rule requiring farmers producing shell eggs to implement measures to prevent SE from contaminating eggs on the farm and requiring farmers producing shell eggs to maintain records concerning their compliance with the final rule and to register with FDA. Sparboe Farms is pleased to acknowledge its compliance and applauds the agency for setting standards for all farmers producing eggs to ensure steps toward producing a safer and more wholesome egg. Sparboe Farms has one specific point to make concerning the Egg Safety Rule testing protocol, i.e., the manure pits of laying hens must be tested at 40-45 weeks of age [21 CFR 118.5(a)]. This protocol specifies dragging a piece of gauze along top the manure. The sampling technique in the rule is outlined below. 21 CFR 118.5(a) FDA Sampling Technique 1. Sampling for verification of an on-farm egg program Manure is the preferred sample type. Use a 10 cm x 10 cm (4 in x 4 in) 12 ply sterile gauze pad which is aseptically attached to a pole by clips or to a string. The clips should be disinfected before each use with 70% ethanol. The gauze pad and string, or gauze pad alone, should be sterilized by autoclaving. Moisten pad with canned evaporated milk, canned skim (fat free) evaporated milk or canned low fat evaporated milk. Disinfect the top of the canned milk with 70% ethanol before opening. The can opener should also be disinfected with 70% ethanol. Place a gauze pad over the opened can of milk to deter flies from contaminating the milk. Use sterile gloves when handling and moistening the pad. Drag the moistened gauze pad over the manure the entire length of one side of the row/bank. Take another gauze pad and drag the other side of the row/bank. Repeat this procedure on all rows/banks of the house. How has Manure Sampling Been Accomplished in the Past? What’s been used in the past for sampling manure is a “Scat Pole”, a long rod with a “V” – hanger at the end and two hanging strings to hold the moistened gauzes. This would be suspended across the “cone” of the manure pile and dragged the length of the cage row. But the problem with this sampling technique is that SE is intermittent shedding so a manure sample only provides the state of infection for a few days. The Dangers in the Manure Pits of Layer Houses It can also be very difficult to walk the manure pit cage row after manure has been collecting for some time. In some cases, it can also be dangerous. The National Poultry Improvement Plan has sampled for SE in the pits of layer houses with the recommendation of using a high quality air respirator (ammonia can burn the cilia in the human trachea) and a coal-miners cap with lantern affixed to the helmet for safety. There’s a more insidious danger. In the Midwestern U.S., cage row housing for laying hens may be 5 rows high. The manure drops down below into a manure pit and will remain there until collected in the fall of the year. If the sampling for SE is done at 42 weeks of age, for example, below each cage will be more than one metric ton of manure. This was calculated by multiplying the number of birds in each cage (6) times the stacked deck of 5 high times 0.25 lbs. of manure per bird per day. Chicken manure is 80% moisture so it is basically a “slurry”. If any additional moisture is added (i.e., leaky watering cup), the added moisture can contribute to the formation of manure “quick-crap” i.e., quicksand-type properties. People have been completely submerged in this quick-crap. Therefore, walking the manure pits is dangerous so we are proposing an alternative: Dry sampling egg belts. We are currently issuing 3M sterile moisture sponges and then following recommended and approved culturing techniques. SE in Environment, But Not in the Egg The discovery of Salmonella Enteritidis in the environment differs markedly from finding SE in the eggs. As reported in Avian Diseases 1994 Jan-Mar;38 (1):37-43. Salmonella enteritidis in eggs from commercial chicken layer flocks implicated in human outbreaks. Henzler DJ, Ebel E, Sanders J, Kradel D, Mason J. U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Veterinary Services, Hyattsville, Maryland 20782. Eggs were cultured from four commercial chicken layer houses implicated in three human outbreaks of Salmonella enteritidis serotype enteritidis infection as part of the activities of the USDA-APHIS, VS, Salmonella enteritidis Task Force. Each house was part of a multiple in-line complex, ranging from three to seven houses. Houses were located on three separate farms, and each house contained between 50,000 and 80,000 chickens. S. enteritidis phage types 8, 13a, and 23 were isolated from samples taken from environmental and organ tissue samples, but only phage type 8 was cultured from eggs. Phage type 8 was isolated from humans in all three S. enteritidis outbreaks. Frequency estimates of contaminated eggs ranged from 0.03% to 0.90%. SE in Environment, But Not in the Chicken The sampling of the ceca of chickens showed on 8.1% positive for SE. Frequency of Salmonella enteritidis and Other Salmonellae in the Ceca of Spent Hens at Time of Slaughter, by D. W. Dreesen, H. M. Barnhart, Julia L. Burke, T. Chen and D. C. Johnson © 1992 American Association of Avian Pathologists, Inc.. A study was conducted to determine the frequency of Salmonella enteritidis (SE) and other Salmonella serovars in the cecal contents of spent laying hens at a hen-processing plant in the southeastern United States over a 4 1/2-month period, from October 1990 through February 1991. A total of 1920 pooled cecal samples (three ceca per sample) from 38 flocks representing 23 producers were obtained and tested for the presence of SE and other Salmonella serovars. A total of 359 samples (18.7%) from 37 of the 38 flocks (97.4%) showed characteristic reactions for salmonellae on triple sugar iron agar (TSIA) slants. Twenty-nine of the 359 Salmonella-positive samples (8.1%) were Group D-positive, all of which were found to be SE on further serotyping. The SE-positive samples were from seven of the 38 flocks (18.4%); four flocks originated from the USDA/APHIS-designated Northern Region of the United States, and three were from the Southeastern Region. A Comparison of Salmonella enteritidis Phage Types from Egg-Associated Outbreaks and Implicated Laying Flocks, by S. Altekruse, J. Koehler, F. Hickman-Brenner, R. V. Tauxe and K. Ferris © 1993 Cambridge University Press. Infections due to Salmonella enteritidis are increasing worldwide. In the United States, between 1985 and 1989, 78% of the S. enteritidis outbreaks in which a food vehicle was identified implicated a food containing raw or lightly cooked shell eggs. Under a US Department of Agriculture regulation published in 1990, eggs implicated in human food-borne S. enteritidis outbreaks were traced back to the source flock. The flock environment and the internal organs of a sample of hens were tested for S. enteritidis. We compared the S. enteritidis phage types of isolates from 18 human, egg-associated outbreaks and the 15 flocks implicated through traceback of these outbreaks. The predominant human outbreak phage type was recovered from the environment in 100% of implicated flocks and from the internal organs of hens in 88% of implicated flocks we tested. The results support the use of phage typing as a tool to identify flocks involved in human S. enteritidis outbreaks. SE Sampling Provides Alternatives The sampling for Se in chickens (broilers) had the highest frequency in paper pads (51%), fly strips (19%) while drag swabs only 14%. Sources and Movement of Salmonella through Integrated Poultry Operations; A Multistate Epidemiological Investigation by J.S. Bailey, N.J. Stern, P Fedorka-Cray, S.E. Craven, N.A. Cox, D.E. Cosby, S. Ladely, and M.T. Musgrove. Richard B. Russell Agricultural Research Center, Athens, GA. Journal of Food Protection, Vol. 64, Nov. 11, 2001, pp 1690-1697 Control of Salmonella is complicated, because there are numerous potential sources of Salmonella contamination in an integrated poultry operation including chicks, feed, rodents, wild birds, insects, transportation, farm environment, and processing plant environment. It is important to be able to characterize the relative importance of the different sources under specific management and environmental conditions. Rodents, particularly mice, have been implicated in the spread of Salmonella Enteritidis, particularly in the layer industry. The sample types with the greatest frequency of Salmonella were paper pads (50.8%), fly strips (18.7%, drag swabs (14.2%) and boot s3abs 12%). All 26 sample types had some Salmonella-positive samples. Conclusions SE found in the environment differs markedly from what’s found in the eggs with a frequency of contaminated eggs from 0.03-0.90%. The frequency of SE in the environment differs markedly from the frequency found in the cecum of chickens at 18.4-88%. Sampling for SE in manure pits is both dangerous to humans and less effective than other forms of sampling including paper pads (51%), fly strips (19%) compared to drag swabs (14%). Dry sampling egg belts is three times more effective at determining whether SE was ever in a layer house as compared to the one time manure sampling technique. For these reasons, Sparboe Farms respectfully requests FDA to specify the dry sampling of the egg belts as an acceptable alternative to the manure pit sampling method. Thank you for this opportunity to provide these comments. Sincerely, Ken Klippen, Ph.D. candidate, M.S., B.S. Hugo Medina, DVM, MS, D.ACPV Executive Director for Government Relations Staff Veterinarian