From: steph engelsman [steph@www.cealonline.org] Sent: Tuesday, December 21, 2004 2:39 PM To: fdadockets@oc.fda.gov Subject: Docket Numbers 1996P-0418, 1997P-0197, 1998P-0203, 2004-0504 December 21, 2004 Division of Dockets Management Food and Drug Administration, HHS 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket Nos. 1996P-0418, 1997P-0197, 1998P-0203 & 2000N-0504; Prevention of Salmonella Enteritidis in Shell Eggs During Production: Proposed Rule To Whom It May Concern: On behalf of the Center for Environmental and Animal Law (CEAL) and its U.S. members, I wish to submit comments on the proposed rule to prevent Salmonella enteritidis (SE) in shell eggs, published in the Federal Register on September 22, 2004. CEAL supports the intent of the Food and Drug Administration (FDA) to establish regulations addressing the occurrence of Salmonella in shell eggs during production. SE continues to pose a significant threat to the American public who consume eggs. As noted in the Federal Register notice, SE illnesses in the U.S. have remained steady for the past several years, despite a goal set in the year 2000 to reduce SE outbreaks and foodborne contamination by 50 percent by the year 2010. The incidence of SE remains much higher than in the 1970s, with an estimated 2.3 million SE-contaminated eggs consumed annually. The Centers for Disease Control and Prevention estimates that these contaminated eggs caused 118,000 illnesses in 2001. The FDA Should Ban Forced Molting As used in these comments, forced molting refers to the process of artificially inducing a molt in laying hens by limiting or withdrawing feed, water, and/or light. Forced molting programs typically deprive hens of feed for up to 14 days and cause body weight losses of 25 to 35% (1). According to the 1999 Layers Study, conducted by the National Animal Health Monitoring System and cited in the FR notice, 83 percent of U.S. egg-laying farms use forced molting. However, the practice is much more common among large operations, with 85 percent of facilities with 50,000 or more layers molting their birds, and only 28 percent of farms with fewer than 20,000 layers molting their flocks. Currently, there are 65 U.S. egg producing companies with more than 1 million layers (2). The purpose of forced molting is to maximize profits. A relatively small number of extremely large egg producers have managed to keep this inhumane practice legal, despite serious concerns regarding the animal welfare and public health impacts. In arguing that forced molting should be prohibited, animal protection advocates cite cruelty to laying hens and the link between the practice and SE infection and transmission. CEAL agrees with both of these arguments. Forced Molting Causes Tremendous Stress in Poultry which in turn Negatively Effects Human Health The FDA repeatedly argues that the issue of animal cruelty is outside the scope of the proposed rule. This is not the case. Other countries often consider animal welfare issues when setting regulations pertaining to food safety. Animal neglect, abuse, and cruelty are prohibited in all 50 states and the federal Animal Welfare Act and Humane Slaughter Act deal almost exclusively with cruelty to animals. It is also well known that stress causes both human and non-human animals to be more susceptible to disease. This fact is directly relevant to the goal of preventing SE contamination of eggs. Hunger is an extremely powerful motivator in chickens and, as a result, food deprivation for forced molting results in severe physiological stress to hens. Evidence of this stress has been demonstrated in a number of research studies, including the following: Meat chickens on restricted feed are chronically hungry (3), show behaviors indicative of boredom and frustration (4), and are more aggressive (5); in one study, hens deprived of food for 3 days increased cage-pecking activities by a factor of 3 and feather pecking by a factor of 8 (6); in another study hens deprived of feed for 21 days at first showed increased aggression and non-nutritive pecking and later showed inactivity, suggesting debilitation (7); feed withdrawal or reduction in chickens causes increased concentrations of plasma corticosterone, an indicator of stress (8); Heterophil to lymphocyte ratios, considered the most reliable physiological index of stress in birds, also increase as a result of feed restriction (9); 48 hours of feed deprivation in chickens results in increased susceptibility to S. aureus (10). In addition, mortality - an indicator of both animal health and animal welfare - has been shown to increase dramatically during forced molting. Support for a Ban on Forced Molting Many animal production and veterinary professionals already agree with animal protection advocates that feed deprivation in forced molting causes animal suffering and stress and should be ended. The United Kingdom has enacted a prohibition on the withdrawal of food, water, and lighting for forced molting. McDonald's and Wendy's corporations have established policies against the use of forced molting by their egg suppliers in the U.S. and internationally. In addition, the Certified Humane and Free Farmed food certifications programs disallow the practice. In 2002, the joint animal welfare program of the Food Marketing Institute and the National Council of Chain Restaurants requested that the U.S. egg industry develop a specific phase-out program for feed-withdrawal molting, and, consequently, in 2003 the scientific advisory committee of the United Egg Producers approved a non-feed withdrawal molt program. Finally, at its 2004 convention the American Veterinary Medical Association approved a resolution in opposition to the withholding of water or food from laying hens for forced molting, noting that the “welfare of birds should be a major consideration in this and any management practice.” A direct connection exists between the welfare of farmed animals, their health and human health. Research has demonstrated that 1) forced molting by feed restriction causes stress to animals, 2) hens undergoing forced molting have an increased incidence of SE infection, and 3) infected hens can transmit SE to their eggs. The FDA should acknowledge the role of forced molting in SE contamination of shell eggs and prohibit the practice. Not only will this prevent unnecessary suffering in egg-laying hens, but it will also help to keep the American public healthy. Thank you for providing CEAL the opportunity to comment on an issue of great interest to our members. Sincerely, Stephanie Engelsman Executive Director CEAL: Center for Environmental and Animal Law 3420 SE Washington Street Portland, OR 97214 http://www.cealonline.org steph@cealonline.org info@cealonline.org References 1. Webster, AB. 2003. Physiology and behavior of the hen during induced molt. Poultry Science 82:992-1002. 2. American Egg Board. U.S. Egg Industry Fact Sheet. Feb. 2004. Available at: http://www.aeb.org. 3. Savory, CJ, et al. 1993. Assessment of hunger in growing broiler breeders in relation to a commercial restricted feeding programme. Animal Welfare 2:131-152. 4. Savory, CJ & Marcos, K. 1993. Influence of degree of food restriction, age and time of day on behaviour of broiler breeder chickens. Behavioural Processes 29:179-190. 5. Mench, JA. 1988. The development of aggressive behavior in male broiler chicks: a comparison with laying-type males and the effects of feed restriction. Applied Animal Behaviour Science 21:233-242. 6. Webster, AB. 1995. Immediate and subsequent effects of a short fast on the behavior of laying hens. Applied Animal Behaviour Science 45:255-266. 7. Webster, AB. 2000. Behavior of White Leghorn laying hens after withdrawal of feed. Poultry Science 79:192-200. 8. Mench, JA. 1991. Research note: feed restriction in broiler breeders causes a persistent elevation in corticosterone secretion that is modulated by dietary tryptophan. Poultry Science 70:2547-2550. 9. Maxwell, MH, et al. 1990. Comparison of haematological values in restricted- and ad libitum-fed domestic fowls: white blood cells and thrombocytes. British Poultry Science 31:399-405. 10. Gross, WB & Siegel, PB. 1982. Socialization as a factor in resistance to infection, feed efficiency, and response to antigen in chickens. American Journal of Veterinary Research 43:20010-20012.